Express Pharma (Vol.10, No.17) July 1-15, 2015

VOL. 10 NO. 17 PAGES 70

www.expresspharmaonline.com

Management FTP 2015-2020: A welcome move Pharma Ally ‘India is the market of the future’

1-15 JULY 2015,` 40

CONTENTS MARKET Vol.10 No.17 JULY 1-15, 2015 Chairman of the Board Viveck Goenka

FTP 2015-2020: AWELCOME MOVE

Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bengaluru Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Arun J Ajanta Sengupta PRODUCTION General Manager B R Tipnis Manager Bhadresh Valia Scheduling & Coordination Mitesh Manjrekar CIRCULATION Circulation Team Mohan Varadkar

12

ANANTH KUMAR RELEASES REPORT ON ENABLING PRIVATE SECTOR TO LEAD GROWTH OF PHARMA INDUSTRY

13

ELDER PHARMA EXPORTS SHELCAL TO OVER 25 COUNTRIES

14

DCG(I) TO FORMULATE GUIDELINES FOR E-COMMERCE MARKETPLACE

17

ASIA LABEX TO BE HELD IN NEW DELHI FROM AUGUST 25-27, 2015

20

PHARMA PRO&PACK EXPO 2015 HELD IN MUMBAI

Pg29 DR GOPAKUMAR G. NAIR, Gopakumar Nair Associates

P18: POST EVENTS Asia Conclave Conference outlines potential in China and Southeast Asia for Indian companies

AJIT J SHAH, Faculty & Trainer in Export & Import

PHARMA ALLY

MANAGEMENT

P28: INSIGHT Robotics in pharmacy automation

P33: CLINICAL UPDATE Boehringer Ingelheim announces OS results from LUX-Lung 8 trial at ASCO 2015

P34: RESEARCH UPDATES BioMarin’s dwarfism drug improves growth in a mid-stage study

P64: INSIGHT Comply or face hefty penalties and jail

37

'WE WILL CONTINUE TO BRING IN LATEST TECHNOLOGY TO INDIA AND HELP ENHANCE SAFETY AND SECURITY'

40 41

‘INDIA IS THE MARKET OF THE FUTURE’

42

LONZA TO EXPAND VIRAL GENE THERAPY BIZ

31

‘SIGNIFICANT IMPROVEMENTS HAVE OCCURRED IN MEDICINE QUALITY IN ASIA’

SCHOTT ACHIEVES GMP CERTIFICATION FOR ALL PHARMA TUBING SITES

Express Pharma® Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express (P) Ltd. by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright © 2015. The Indian Express (P) Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

TRIPS-ing time again

T

he recent TRIPS Council meeting (June 9-10) once again saw a confrontation between leastdeveloped countries (LDCs) and developed countries on two major issues. The first was the extension of a waiver allowing LDCs to forgo enforcement of IPRs on pharmaceutical products until their economies are more stable. While most developed countries, led by the US and Switzerland, continue to argue against this extension, Norway, a high-income member of the WTO, has supported this LDC Group request acknowledging that “as long as a member is an LDC, it will have institutional and financial constraints, as well as lack of adequate technological base and pharma manufacturing capacity and will therefore need flexibility and maximum policy space to enable it to confront its health challenges with effective and affordable strategies.”

The second issue debated at the meeting was the LDC Group's stance that non-violation complaints (NVCs) should not be allowed at the WTO Dispute Settlement Body (DSB). According to the WTO's backgrounder on NVCs, such complaints arise when governments complain to the WTO DSB claiming that 'it has been deprived of an expected benefit because of another government’s action, or because of any other situation that exists.'

Industry observers point out that the US has

When governments of LDCs and developing countries have to weigh public health against IP issues,they really have no choice but to plug for the former

threatened to take India to the WTO DSB, arguing that sections of India's patent law, like Section 3(d), though not violating any WTO agreements, subvert the principles of protection of IPRs, which is the obligation of every country. But the reality is that when governments of LDCs and developing countries have to weigh public health against IP issues, they really have no choice but to plug for the former.

India is one of 17 nations which co-sponsored a paper introduced by Brazil which basically made the case that NVCs go against the spirit of TRIPS. India's strongly worded statement asks important questions regarding the circumstances under which they will be used “to suppress members sovereign policy space”, the limits on NVCs and the policy measures that will come under its scanner.

Informal discussions on both issues will continue till the next TRIPS Council meeting scheduled for October 15-16 but will the LDCs and developing countries be able to stand their ground in the face of rising litigation cost?

The irony is that developed nations advocate NVCs to "discourage members from engaging in 'creative legislative activity' that would allow them to get around their TRIPS commitment", as the WTO backgrounder on NVCs puts it. With such good intentions on both sides, why does a resolution still seem so far away?

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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MARKET COMPANY WATCH

Ananth Kumar releases report on enabling private sector to lead growth of pharma industry Recommendations were put forward towards concerns and constraints facing the sector and suggested measures that would augment domestic production THE UNION Minister of Chemicals and Fertilisers, Ananth Kumar has released task force report on enabling the private sector to lead the growth of pharmaceutical sector. The minister said that the government wants to encourage a robust pharma industry in the country that is upgraded, standardised, innovative, globally competitive and can produce formulations at affordable costs.

He said in this regard, setting up of the task force was one of the major initiative of the government.

According to a PIB release, the task force has given recommendations towards concerns and constraints facing the sector and suggested measures that would augment domestic production. Ananth Kumar said that the government is keen on early implementation of the rec-

The task force has recommended measures to enhance regulatory support; suggested strengthening of infrastructural support; and recommended fiscal and financial support to the sector ommendations of the task force and it would come out with an action taken report on these recommendations in 100 days.

Speaking on the occasion, Minister of State for Chemicals and Fertilisers, Hansraj Gangaram Ahir said that the government is promoting ‘Make in India’ as well as ‘Skill India’ Mantras of the Prime Minister.

He said that the pharma sector has to compete globally and for this, better standards and improved facilities are required.

Ahir said that the government is willing and keen to facilitate the growth of pharma sector in the country.

Dr VK Subburaj, Secretary, Department of Pharmaceuticals, said that the exports of pharma by Indian companies is a success story. However, regulations in the sector are weak in the country and that is affecting the further growth. He said that the department has taken several steps to bring awareness in the industry for improving the

standards. Subburaj further said that pharma sector is also suffering due to multiple decision making authorities. The task force has recommended a joint committee which can take care of their problems.

To provide thrust to the sector, a task force on enabling the private sector to lead the growth of pharma sector was set up by the Department of Pharmaceuticals. The task force was headed by secretary, Department of Pharmaceuti-

cals and consisted of representatives from Planning Commission, the Department of Industrial Policy and Promotion, Department of Science and Technology, Department of Biotechnology and various Industry Associations including IPA, IDMA, BDMA, OPPI, AIMED, CIIO, FICCI, ASSOCHAM, FOPE etc. The task force has recommended measures to enhance regulatory support; suggested strengthening of infrastructural support; and recommended fiscal and financial support to the sector. In addition, the task force has also recommended measures for promoting skill development aligned to the need of the industry, strengthening the R&D capability of the sector, pricing strategy for the sector.

EP News Bureau-Mumbai

Syngene International gets FIPB approval Foreign investment limit raised to 44 per cent SYNGENE International, a leading India-based contract research organisation (CRO) and a subsidiary of Biocon, has received the Foreign Investment Promotion Board (FIPB) approval for raising the foreign investment to 44 per cent from the earlier approved 10 per cent by way of its Initial Public Offering (IPO).

Commenting on the development, Peter Bains, Chief Executive Officer, Syngene International said, “We are happy to

12

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July 1-15, 2015

receive the FIPB approval to increase the foreign investment limit in our company. Syngene supports the global pharma, biotech and life science industries. This approval will enable us to look to broaden our global investor base.”

The IPO is an offer for sale (OFS) by Biocon of a part of its shareholding in Syngene. The Biocon Group presently holds 83.6 per cent equity stake in Syngene. Syngene reported revenues of ` 7,077 million for

FY 2013-14 and ` 6175 million for nine month ended December 31, 2014. For the three fiscal years ended March 31, 2014, its total revenue, restated profit and EBITDA grew at compounded annual growth rates (CAGR) of 29.9 per cent, 70.5 per cent and 30.6 per cent, respectively. Its flexible business models, expertise in managing large integrated collaborations and world-class infrastructure has not only helped it renew and expand its

existing client collaborations but also in attracting new clients. Syngene’s client base increased 90 per cent from 103 in FY 2012 to 195 as on December 31, 2014.

It has long term multi-disciplinary partnerships with three of the world’s leading global healthcare organisations, Bristol-Myers Squibb Co. BMS, Abbott Laboratories (Singapore) and Baxter International and has set up dedicated R&D Centres for each of

them. The dedicated R&D Centre of BMS is its largest R&D presence in Asia with more than 400 scientists.

On January 12, 2015, Biocon Research transferred a 10 per cent stake in Syngene to IVF Trustee Company for a consideration of ` 3,800 million. The equity shares are proposed to be listed on the BSE and the National Stock Exchange of India.

EP News Bureau-Mumbai

Elder Pharma exports ShelCal to over 25 countries which will market it across the EU. Sold through the ethical route, Shelcal has found support from health conscious persons as the source of calcium used in Shelcal is from ‘oyster

The company targets ` 100 crore from global sales

shell’, which provides calcium in its purest form. Because of its organic origins, it is highly bio-available and gives significant increase in BMD (Bone Mineral Density). Other cal-

WITH INTERNATIONAL rights for Shelcal still with Elder Pharmaceuticals, the company has aggressively started marketing this brand globally.

Elder Pharma has already started exports of its leading calcium supplement brand to about 25 countries with many more on the anvil.

For the year 2015-16, the company is likely to notch up sales of over ` 25 crore and the demand is coming from some of the most unusual countries like Cambodia, Myanmar, Sri Lanka, Mauritius, Maldives, Zambia, Uganda, Yemen, Guyana, Burkinafaso, Cameroon, Congo, Ivory Coast, Gabon, Papua New Guinea, Mali, Mauritania, Niger, Senegal, Burundi, Rwanda etc. Shelcal is currently exported in the form of 250/500 mg tablets and Syrup but new line extensions are also being planned which will include Shelcal CT (Calcitrol), Shelcal OS (alpha Calcitrol) and Shelcal HD (high dosage of Vitamin D3).

Alok Saxena, Chairman and Managing Director, Elder Pharmaceuticals said, “About a year back, Elder had sold the rights for the domestic markets of Shelcal and 30 other brands to Torrent group for a consideration of ` 2000 crore but had retained the rights for the international markets with itself.

With overwhelming response and acceptance of its product in all these markets, the company is looking at strong prescription base in over 70 countries by March 2017.”

Elder is also targeting the markets of Europe, CIS and LATAM. Shelcal’s European thrust will be spearheaded by Neutra Health plc, its wholly owned subsidiary in the UK

EXPRESS PHARMA

13

July 1-15, 2015

cium supplements have synthetic origins and hence their contribution to BMD does not match up to Shelcal. Shelcal’s success also stems from the fact that it targets different

segments like management of calcium deficiency, osteoporosis, pregnancy and lactation and is suitable for all ages.

EP News Bureau-Mumbai

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MARKET

DCG(I) to formulate guidelines for e-commerce marketplace FICCI appointed as the nodal agency for consolidating the guidelines THE ROLE, responsibilities and liabilities of e-commerce marketplace and the product sellers need to be clearly defined. It becomes even more critical to have a framework in place when the intermediary is selling drugs where the safety and health of the consumer is of paramount importance. This was stated by Dr GN Singh, Drugs Controller General (India) at a FICCI consultative meeting on ‘Pharma Guidelines for Reinforcing Due Diligence for Intermediaries (E-commerce Marketplace)’ in New Delhi.

FICCI talks of due diligence by marketplace to ensure consumer safety while selling of drugs online. FICCI has been appointed as the nodal agency by the DCG(I) for consolidating the guidelines and was seeking views of OPPI, All India Chemists and Druggists Association, States Chemists and Druggists Associations, Indian Medical Association, CIPI, BDMA, PHD Chamber of Commerce and Industry and consumer forums, in this regard.

Singh said that pharmaceuticals industry needs a new regulatory framework to effectively bring e-pharmacy under its am-

FICCI talks of due diligence by marketplace to ensure consumer safety while selling of drugs online. FICCI has been appointed as the nodal agency by the DCG(I) for consolidating the guidelines

bit. The Drugs and Cosmetics Act does not have any guidelines for e-commerce players in pharma. Hence, it is essential to create guidelines for e-pharmacy that checks efficaciously the use of technology as safety of patient, quality of drugs and robust supply chain are prerequisites for DCG(I).

With the advent of technology, e-commerce industry has entered in healthcare space in the form of e-pharmacy. However, there are issues such as complaint being filed against ecommerce player/s for online sale of prescription based drugs. To resolve these issues, Singh suggested that it would

be beneficial for the regulator to engage with stakeholders in constructive brainstorming deliberations to reach a consensus. He added that the Indian Government was forthcoming in adopting industry’s recommendations and the DCG(I) would assist in providing a legal status to implementable suggestions of industry.

Singh assured that the interest of small retailers will be protected and it would be ensured that e-pharmacy does not disturb the existing supply chain system in place. The aim would be to integrate e-pharmacy in the existing system. Besides industry, in the consultative meet-

ings, consumers, doctors and pharmacists should be adequately represented to have a holistic view on the issue, which would enable formulation of an innovative policy framework.

He added that the Indian regulatory body was also engaging with international regulators in the space to derive a forward looking policy.

Dr Arbind Prasad, Director General, FICCI, said that FICCI in consultation with stakeholders had prepared a representation for DCG(I) titled ‘Suggestive Guidelines for Reinforcing Due Diligence for Intermediaries (E-Commerce Marketplaces)’. He informed that the document comprehensively discusses the challenges faced by the sector and also proposes recommendations which can be deliberated upon to resolve these issues.

During the meeting, Singh actively interacted with the stakeholders, noted their concerns and responded to their pertinent queries. Among the stakeholders who spoke on the occasion was Dr KK Aggarwal, Honorary Secretary General, Indian Medical Association.

EP News Bureau-Mumbai

US FDAwarns over 1,000 illegal online medicine sellers THE US Food and Drug Administration has sent warning letters and held potentially dangerous, unapproved medicines and medical devices from more than 1,050 websites worldwide.

The FDA has seized illegal drugs and medical devices received through international mail facilities in Chicago, Miami and New York. The drugs seized include some purported to be the generic versions of FDA-approved drugs like Nolvadex, Meridia, Valium, Truvada and Advair Diskus.

Reportedly, the devices sold illegally through websites included colon care products and dermal fillers. The health regulator stated that the illegal sale of such products and drugs caused not only health risks but also put the consumers at risk of credit card fraud, identity theft and computer viruses.

Reportedly, the crackdown is a part of the INTERPOL-led International Internet Week of Action (IIWA), an endeavour to fight the unauthorised sale and distribution of illegal and counterfeit medical products.

Reuters

Intas launches RAZUMAB Ranibizumab is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD), a common degenerative condition of the eyes in the elderly INTAS PHARMACEUTICALS has launched RAZUMAB, its biosimilar to Lucentis (ranibizumab). Intas is the first company globally, to develop and launch a biosimilar version of ranibizumab.

RAZUMAB is manufactured under strict guidelines for sterile use in the eye and is offered as single dose vial, thus

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July 1-15, 2015

reducing the risk of contamination during use.

Ranibizumab is a therapeutic antibody fragment designed specifically for treating degenerative conditions of the eye. It blocks the production of vascular endothelial cell growth factor A (VEGF-A), a protein which when over expressed leads to abnormal

blood vessel growth in the retina, that can cause leaks and vision loss.

Ranibizumab is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD), a common degenerative condition of the eyes in the elderly. It is also indicated for Macular Edema following Retinal Vein Occlu-

sion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy in patients with Diabetic Macular Edema and vision loss resulting from choroidal neovascularization in pathologic myopia (mCNV).

“Intas’ ranibizumab, RAZUMAB is a 100 per cent ‘Made In India’ molecule, a feat achieved by the scientists at

Intas and unparalleled till date.

With the mission to provide global healthcare at affordable costs, RAZUMAB will be about 25 per cent cheaper than the imported Lucentis in the hand of the patient,” said Binish Chudgar, Vice Chairman, Intas Pharmaceuticals.

EP News Bureau-Mumbai

MARKET GROWTH TRACKER

IPM clocks ` 7717 crores in May 2015 Eight therapies have outgrown the IPM growth THE INDIAN pharma market (IPM) clocked ` 7717 crores in May 2015. The market grows at 11 per cent in May 2015.

Amongst the top 10, Sun grew by 19.9 per cent followed by Cipla at 15.4 per cent and Abbott at 13.2 per cent. 23 corporate have crossed the growth of IPM for May 2015 amongst top 50.

Amongst the top 50 corporate, Akumentis has the highest growth of 29.1 per cent followed by Glenmark at 28.9 per cent and Torrent at 27 per cent. 25 corporate showed growths more than 10 per cent amongst the top 50. Amongst the 1120 ranked corporate, Glenmark has the highest growth of 28.9 per cent followed

by Torrent at 27 per cent and Aristo at 21.7 per cent.

Amongst the 21-30 ranked corporate, MSD has the highest growth at 23.9 per cent per cent followed by Wockhardt 21.2 per cent and Alembic at 15.1 per cent.

Amongst the 31-40 ranked corporate, Akumentis has the highest growth at 29.1 per cent followed by Merck at 21.3 and Bharat Serums at 18.7 per cent.

Amongst the 41-50 ranked corporate, Allergan has the highest growth at 26.8 per cent followed by Wallace at 11.6 per cent and Apex at 11.5 per cent. Amongst the 51-60 ranked corporate, Eli Lilly grew at 34.4 per cent followed by Troikaa at 27 per cent and Centaur at 23.7 per cent.

Amongst the 61-70 ranked corporate, Boehringer grew at 61.1 per cent followed

by Fresenius Kabi which grew by 53.9 per cent followed by RPG at 29.6 per cent.

Glenmark entered the ` 2000-crore mark, Natco ` 100 crore on MAT Basis.

Amongst the top 10, Sun Pharma grew by 23.2 per cent followed by Cipla at 15.4 per cent and Ranbaxy at 14.7 per cent. 24 companies have crossed the growth of IPM for the month of May 2015 amongst top 50. Amongst the 11-20 ranked companies Glenmark has the highest growth of 28.9 per cent followed by Torrent at 27 per cent and Aristo at 21.7 per cent.

Amongst the 21-30 ranked companies, Wockhardt has the highest growth at 21.2 per cent followed by Alembic 15.1 per cent and Zuventus at 13.3 per cent.

Indian companies have grown at 11.2 per cent versus 10.2 per cent for MNCs in

May 2015. Amongst the top 50 in MNCs Allergan grew by 26.8 per cent followed

by MSD at 23.9 per cent and Merck at 21.3 per cent. Under the non-NLEM category, Indian companies grew at 4.7 per cent whereas MNCs grew at 6.9 per cent.

The DPCO containing molecules market grew at 5.3 per cent whereas the non DPCO market grew by 12.1 per cent and non-Sch Para 19 Market at 7.2 per cent resulting in an overall growth of 11 per cent for May 2015. NLEM and non 窶年LEM Category showed unit growth at -0.3 per cent and 3.4 per cent respectively. The non-Sch Para 19 market grew at 4.3 per cent from units perspective The DPCO 2013 portfolio for Pfizer grew at 5.7 per cent, Ranbaxy 29.5 per cent, GSK at -1.2 per cent and Abbott 18.5 per cent.

From therapy perspective, eight therapies have outgrown the IPM growth. The respiratory market grew at 11.9 per cent, gastrointestinal market grew at 14.2 per cent, pain and analgesics market grew at 8.5 per cent whereas anti-infectives grew at 5.5 per cent. The anti-diabetic market grows at 20.7per cent and cardiac at 10.7 per cent in chronic business. The derma market grew by 20 per cent and urology market at 23 per cent.

From regional perspective, 12 regions have outgrown the IPM growth. The UP East market grew the highest at 24.8 per cent followed by North East market at 21.7 per cent and North AP Market at 18.2 per cent. Two regions had negative growth in May 2015.

Amoxycillin + Clavulanic acid market grew at seven per cent whereas Glimepiride + Metformin grew at 10 per cent at number two.

The markets of paracetamol grew at 1.1 per cent, Atorvastatin 5.2 per cent, Probiotic Microbes at 26.1 per cent, Cefixime 3.8 per cent, Pantoprazole 15.3 per cent, Montelukast + Levocetrizine at 23.7 per cent, Glimepiride + Metformin + Pioglitazone at 13.9 per cent, Vitamin-D at 26.3 per cent, Hydroquinone + Mometasone + Tretinoin at 4.9 per cent, Voglibose + Metformin + Glimepiride at 47.7 per cent, Rosuvastatin at 22.9 per cent, pro-

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July 1-15, 2015

MARKET tein supplements at 16.3 per cent, Azithromycin at 9.1 per cent.

Mixtard leads the pack with ` 32 crores followed by Augmentin at ` 20.56 crores and Glycomet GP at ` 24.23 crores for May 15. Glycomet – GP crosses the ` 300 crore-mark to join with Augmentin in ` 300-crore league. Monocef grew by 25.7 per cent followed

by Lantus at 24.6 per cent, Becosules at 23.1 per cent, Corex at 21.9 per cent and augmentin at 19.9 per cent amongst the top 10 brands.

Few brands which have gained ranks include Chymoral Forte (+122), Phensedyl Cough (+93), Janumet (+79), Januvia (+68), Pentaxim (+62), Betnesol (+59), Betnovate C ( +56), Shelcal (+55), Panderm Plus (+46), Huminsulin (+36), Mox (+28), Clexane (+24), Zoryl- M (+23), Istamet (+22), Pantocid D SR (+21), Spasmo Proxyvon Plus (+19), Orofer XT, Rosuvas andLevipil (+16), Magnex & Aztor (+15), Jalra-M (+14), Mifegest Kit & Monocef O (+12), Galvus (+11), Omez and Pantodac (+10) amongst top 100 Brands over April 2014. A total of 224 brands and 377 SKUs were launched in May 2015. Top new brands for May were Zotide, Forxiga and Viroclear.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted

by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage.

For more information, visit http://www.aiocd.net

16

EXPRESS PHARMA

July 1-15, 2015

With Bonus Units at Full Value Val in Crs

Rank

CORPORATE

MAT

MAT May -15 MTH

IPM

May-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

88948

100.00

14.0

7717

100.00

11.0

Sun + Ranbaxy

1

1

7891

8.87

14.0

746

9.67

19.9

Abbott + Abbott HC + Novo

2

2

5500

6.18

12.5

470

6.09

13.2

Cipla

3

3

4474

5.03

17.6

377

4.89

15.4

Zydus + Biochem

4

4

3706

4.17

8.5

311

4.04

5.0

Mankind

5

5

3191

3.59

16.7

275

3.56

12.4

Alkem + Cachet + Indchemie

6

6

3144

3.54

13.1

260

3.37

6.5

Glaxo

7

8

3070

3.45

4.3

251

3.26

0.6

Lupin

8

7

2955

3.32

14.7

255

3.31

0.6

Pfizer

9

10

2656

2.99

17.1

222

2.88

10.2

Macleods

10

9

2626

2.95

27.6

223

2.88

12.1

Emcure + Zuventus

11

12

2391

2.69

10.2

205

2.65

6.0

Intas

12

11

2354

2.65

19.0

216

2.80

20.3

Sanofi

13

15

2243

2.52

16.5

183

2.38

3.2

Aristo

14

13

2230

2.51

20.0

197

2.56

21.7

Torrent

15

14

2059

2.31

20.7

194

2.52

27.0

Glenmark

16

16

2003

2.25

20.0

172

2.22

28.9

Dr. Reddys

17

17

1882

2.12

14.5

168

2.18

15.4

USV

18

18

1740

1.96

19.3

162

2.10

15.9

Val in Crs

MAT May 15

Month May-15

Super Group

VAL IN CRS

GR%

VAL IN CRS

GR%

IPM

88948

14.0

7717

11.0

ANTI-INFECTIVES

14054

10.7

1110

5.5

CARDIAC

11021

13.7

983

10.7

GASTRO INTESTINAL

10290

16.1

978

14.2

VITAMINS / MINERALS / NUTRIENTS

8060

13.4

719

8.9

RESPIRATORY

7010

14.2

510

11.9

ANTI DIABETIC

6942

25.7

639

20.7

PAIN / ANALGESICS

6190

12.2

535

8.5

NEURO / CNS

5351

11.0

479

10.5

DERMA

5195

17.8

466

20.0

GYNAECOLOGICAL

4418

9.1

396

9.2

VACCINES

1484

4.7

123

0.1

HORMONES

1477

7.7

122

2.8

ANTI-NEOPLASTICS

1453

23.5

124

6.1

OPHTHAL

1302

17.4

120

12.4

OTHERS

998

22.5

99

22.2

BLOOD RELATED

992

8.2

89

9.8

UROLOGY

961

25.6

91

23.0

ANTI MALARIALS

550

4.8

35

-10.2

SEX STIMULANTS / REJUVENATORS

483

8.3

41

8.6

STOMATOLOGICALS

380

12.7

33

2.7

OPHTHAL / OTOLOGICALS

228

7.9

19

-2.8

OTOLOGICALS

107

11.2

8

17.0

MARKET PRE EVENT

Asia Labex to be held in New Delhi from August 25-27,2015 Will see participation from lab professionals, buyers and trade suppliers of focal industries and institutions ASIA LABEX, an international exhibition and conference on laboratory, analytical, biotech and diagnostic instruments and consumables will be held from August 25-27, 2015 at Pragati Maidan, New Delhi. Around 200 plus exhibitors from 15 countries, 1800 brands will tale part in the event. Around 20 seminar topics will be discussed in the expo and seminar. The exhibition will provide an opportunity to the participants to connect with global leaders, learn about cutting-edge technology, hear about vital research and appreciate the changes the industry is going to witness in near future.

The focus of show will be on the latest trends and technology in the area of laboratory and analytical instrumentation, chromatography and spectroscopy, biotechnology and life sciences, process control and reactors, medical and clinical diagnostic, clean room and sterilisation, quality control and environmental, educational labs, measurement and testing, liquid handling and filtration, laboratory consumable and allied products, laboratory furniture and construction.

The event will have participation from companies like Thermo Fisher, Perkin Elmer, Agilent, Brand Scientific, Borosil, Merck, Sartorius, Hallma, Horiba, Thomas Baker, Labguard among others.

EP News Bureau-Mumbai

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MARKET POST EVENTS

Asia Conclave Conference outlines potential in China and Southeast Asia for Indian companies Senior leaders from IMS Health in the region presented a wide range of insights on the Chinese and Southeast Asian markets IMS HEALTH recently hosted the Asia Conclave Conference in Mumbai to address the challenges and opportunities for Indian pharma companies in China and Southeast Asia. Around 50 stakeholders from pharmaceutical, private

equity and other healthcare companies took part in the event.

Senior leaders from IMS Health in the region presented a wide range of insights on the Chinese and Southeast Asian markets as

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MARKET

KEY INSIGHTS DISCUSSED ◗ Urbanisation is the primary driver of growth in the pharma market, affecting increases in patient affordability and access as well as overall government healthcare spending.

investments and capture a strong position in China.

“To sustain success in China, understanding and responding to the unique market dynamics and needs is paramount,” asserted Zhang.

“Here, proactive, creative and diverse models will be the winners.”

Shifting focus to Southeast Asia, Amit Backliwal, Vice President, Technology and Services, IMS Health China and South East Asia, presented a comprehensive evaluation of region, categorising it into four key markets: Mature, Maturing, Emerging and Frontier. Echoing his col-

leagues’ insights on China, Backliwal urged an informed approach to entering these markets, stressing the need to customise strategies to the potential and maturity of each. And, with familiar challenges on the horizon, including cost containment and pricing pressures, attendees

were advised to take a longterm view of success.

Similar events will be conducted in coming months by IMS to unveil other potential regions (such as Latin America, CIS, Japan, etc.) for Indian companies.

EP News Bureau-Mumbai

◗ In China’s primary healthcare market – hospitals – local companies continue to perform well, and are increasingly becoming strong competitors for MNCs. ◗ The recent slowdown in growth can be attributed to hospital cost contaminant, the expansion of the essential drug system, pricing pressures, and new provincial tendering trends. ◗ Anti-corruption initiatives are expected to increasingly regulate physician prescribing behaviour and require science-driven engagement strategies. ◗ Generic drugs are facing a wide range of regulatory challenges, from registration and pricing parameters, to branding and hospital listing requirements.The volume of this market, however, is still set to rise as a result of the recent patent cliff, opening significant opportunity for API manufacturers.

well as recommendations for companies looking to enter or expand in these geographies.

Of particular focus throughout the day was the current market and regulatory environment in China.

Nitin Goel, General Manager, IMS Health South Asia and Meng Zhang, Managing Principal, IMS Consulting Group China, offered attendees an in-depth review of the country’s most pertinent dynamics.

To address these levers, IMS Health offered a range of recommendations for companies to maximise their

EXPRESS PHARMA

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PHARMAPro&Pack Expo 2015 held in Mumbai 471 exhibiting companies, 18,000 trade visitors from India including 580 hosted international buyers from 124 countries took part in the event

FULFILLING THE requirements and needs to promote internationally the Brand INDIA in pharmaceutical segment, PHARMA Pro&Pack Expo 2015 and concurrent event, PharmaLAB Expo 2015 (organised by IPMMA and GPE EXPO) co-located with iPHEX 2015 (organised by PHARMEXCIL) was recently held at Mumbai Exhibition Center, Mumbai.

The event witnessed participation from 471 exhibiting companies and was attended by over 18,000 trade visitors from India including 580 hosted international buyers from 124 countries.

The concurrent trade shows were inaugurated by Hansraj Gangaram Ahir, Union Minister for Chemicals and Fertiliser and Girish Bapat, Minister for Food & Civil Supplies. The trade shows also saw visits from a senior six-member government delegation from Sri Lanka.

Giving the inaugural address, Ahir said, “The government is focusing on bulk drug manufacturing which will get a further boost with setting up of ‘Mega Parks’ and which is also aligned to Prime Minister Narendra Modi’s Make-in-India programme.” He sounded optimistic about the overall and future prospects of the Indian pharma sector, which exports to over 200 countries worldwide and also expects that it will also give a boost to GDP growth of the country.

Bapat, opined that the shows will help boost prospects of the pharma industry and also since India is turning in to a ‘Pharma Capital’ of the world.

Rajeev Kher, Union Commerce Secretary added that an inter-ministerial committee report has recommended that bulk drug manufacturing should be revived in the country.

Dr PV Appaji, Director General, Pharmexcil said, “Our

20 EXPRESS PHARMA July 1-15, 2015

main focus is to get the recognition of Indian Pharmacopoeia from drug regulators, for which, we are speaking to all drug regulators and reassuring them that Pharmexcil would make its best efforts to ensure supply of best quality drugs at affordable prices.”

On the sidelines of the trade show, Drugs Controller General (India) GN Singh said, “Indian regulators are stringently implementing regulatory systems to further boost business prospects.”

“We have to meet challenges related to documentation and data integrity and also renew focus on quality of drugs that are produced in India,”

said Sudhanshu Pandey, Joint Secretary, Ministry of Commerce.

According to Rattan Singhania, President, Indian Pharma Machinery Manufacturers’ Association (IPMMA), the PHARMA Pro&Pack Expo exhibitions are assisting to create numerous business opportunities for Indian pharma machinery manufacturers in the Indian as well as the overseas markets, due to the sheer number of trade visitors who visited the shows from India and abroad.

The exhibition also provides a strong business platform to even a smallest entrepreneur to display his technical skills to national and international pharma

buyers. Moreover, the exhibition remains a healthy trade domain for every exhibiting company with equal opportunity of growth and meet all the trade attendees at the show.

Such international trade events happening at our doorsteps play most important roles to nurture the domestic business of pharma machineries and lab equipment manufacturers and encourage the solution provider to business in fair and transparent trade-ecology.

With the launch of this exhibition, PHARMA Pro&Pack Expo during year 2013 itself, it has emerged as the largest most Brand INDIA pharma machinery and lab equipment Exhibi-

tion in the Indian sub-continent, and in coming years, it will be growing in multi-folds to accommodate more number of national and international pharma machinery manufacturers and solution providers in bigger way, added Singhania.

Looking to the response to PHARMA Pro&Pack Expo 2015, Mumbai Exhibition from the industry, Mahendra Mehta, Chief Executive Officer, Parle Global Technologies and Treasurer, IPMMA conveyed, “This third edition has been beneficial in terms of foreign delegates visiting our booth and considering the Make-in-India programme initiated by the current government, it was very

MARKET interesting to have foreign buyers coming and inspecting our products.” Speaking about the quality of products made by Indian pharma machine manufacturers and Parle Global in particular, Mehta said, “Seeing is believing and when you showcase and demonstrate the working of your products to buyers at the show, the product speaks for by itself.”

“As far as the qualities of the displays are concerned, I see a distinct improvement over the past two years. The exhibitors have also turned more responsive when compared with the past two editions,” Vishvesh Parekh, Director, Income Group.

“This is my repeat visit to the show. This time I have noticed a distinct difference between the show held last year and this year. The display has

The concurrent trade shows, PharmaLAB Expo 2015 co-located with iPHEX 2015 were inaugurated by Hansraj Gangaram Ahir, Union Minister for Chemicals and Fertiliser and Girish Bapat, Minister for Food & Civil Supplies.

The trade shows also saw visits from a senior six-member government delegation from Sri Lanka vastly improved and exhibitors too went out of their way to address queries from visitors,” AC Tiwari, Senior Vice President, IPCA Laboratories.

“I am happy to attend the shows here and it was very interesting to come across new technologies and developments in the field of pharma ma-

chineries. The best part is that along with iPHEX, the shows put together showcase the entire spectrum of the Indian pharma industry,” Dr SP Rijhwani, Promed Laboratories, Indore and Vice President – Indian Pharmaceutical Association (IPA).

“I had come here for the first

edition and this is my second visit. When comparing with the previous shows, I find 2015 show to be bigger with many more new technologies on display and is also well organised.

These technologies on display here will help us select machines as and when we decide to buy new machines,” Anil Ku-

mar, Plant Head, Alkem Laboratories.

Olubunmi Olaopa, President, West African Pharmaceutical Manufacturers Association and Group Managing Director of Evan Medical, Nigeria, said, “The exhibition was encouraging for the international buyers those who had attended. I have visited many exhibitions, but this is the best one. I had visited the one held last year and the level of this time is much better than the last year’s edition. The best part of the PHARMA Pro&Pack Expo 2015 is that everything can be seen under one roof. Indian pharma machinery and equipment is of very high quality and affordable and most of all, I am impressed by the support of your government to this expo.”

“The PHARMA Pro&Pack Expo 2015 is well organised and

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MARKET at this just one trade show, I have been able to see all kinds of pharma machinery,” Shafiuzzaman, Secretary General, Bangladesh Association of Pharmaceutical Industries, Bangladesh.

“According to me, if we want to upgrade our facilities and improve the quality of our products, this exhibition offers machineries and equipment at affordable costs. The technology on display is the latest and I expect that this show will continue to be held every year in the future too. Maybe next year, I will send a technical team from our plant. In closing, I can only say that it has been a fruitful visit,” Mohammed Zakir Hussein, Delta Pharma, Bangladesh.

“This is my first visit to the exhibition and I really cannot believe that Indian pharma machine manufacturers can develop and produce such hightech machinery. I have spoken with a few exhibitors here for permanent transfer of technology to Egypt and that is where I see future cooperation between India and Egypt,” Dr Ardil Mustufa, Chairman, Pharmaceutical Holding Company, Egypt.

One of the buyers from the US, Hemant Joshi reviewed the Exhibitions and said, “It was a wonderful experience for me as I have never visited such an expo in India. I have been to may exhibitions in the the US, however, the PHARMA Pro&Pack Expo 2015 is comparable to those held in the US. Talking about the technologies on display, I came across many latest types of machineries. I came across two to three producers of that equipment. I can say that Indian pharma manufacturers are at par with those in the US. Secondly, the prices of Indian machines are very affordable to those available in the US.” “I am using Indian pharma machines for the past 20 years and I have seen the industry progress over the period. It has really improved in terms of finishing and GMP. In fact, I feel some of the manufacturers have actually set standards for others to follow”, said Sunil Shah, Kenya during his threeday visit at PHARMA

22 EXPRESS PHARMA July 1-15, 2015

Pro&Pack Expo 2015, Mumbai Exhibition.

Consecutive third time exhibiting, David Keefer, President, Elizabeth Carbide Die Co, US said, “We are exhibiting at this expo for the third time and profile of the buyers who visit our booth fits in perfectly with the products that we manufacture. Buyers are spending a lot of time reviewing our machinery and we successfully closed a few orders with the buyers who visited our booth. We are a joint venture partner with Parle Global Technologies and they too are happy with the results that we generate from this show.”

PHARMA Pro&Pack Expo 2015 also hosted a Reverse Buyer-Seller Meet (RBSM) which saw participation from over 70 international buyers and helped Indian pharma machine and equipment manufacturers have a one-to-one interaction with these foreign buyers. At the same time, PHARMEXCIL invited and

The trade shows also saw visits from a senior six-member government delegation from Sri Lanka

hosted 498 international buyers at the exhibition.

The fundamental reason behind hosting the BSM was to promote ‘Made-in-India’ pharma machinery and engineering to the worldwide pharma markets and the BSM strived to directly support

and encourage the Indian pharma machinery export trade, especially those from the SME sector.

The show offered ample business opportunities to SME’s to showcase their engineering skills to serious buyers on a proven business platform and for first time exhibiting companies to showcase and launch new products and services to around 18,000 trade visitors.

The PHARMA Pro&Pack 2015 Expo was held with encouragement from the Government of India through EEPC India, an agency set up by Ministry of Industry & Commerce to promote pharma engineering products and services.

Among so many, one of the most satisfied exhibitors, Kedar Sathe, Director Arbess Tools, said; “We are a repeat exhibitor at the PHARMA Pro&Pack Expo and we are happy with the way the show has been organised. Just like last year, we are really im-

pressed with the quality of international visitors who are here. Additionally, since this show is being held alongside iPHEX, the show generates extra exposure, since our machinery users are part of the iPHEX show.”

Sushil Mishra from Gandhi Automation, manufacturer of automatic rolling shutters, said, “We have found a lot of enthusiasm for our products from visitors. We found the inquiries to be very positive as there are many companies which want to upgrade their existing technologies and equipment.”

“With increasing R&D spends, Indian pharma sector has become a cost-effective centre for world class research as also for contract R&D. Indian companies in recent years have produced many cost-effective drugs that are affordable to the masses,” concluded Ashutosh Gupta, chairman, Pharmexcil.

“We are making concerted efforts to promote India’s status as the manufacturing hub of the world,” added Gupta.

Bhavin Mehta, Committee Chief, iPHEX and CoA member, Pharmexcil said, “iPHEX 2015 will be a complete value chain show and Pharmexcil is creating a sustainable pharma industry platform with a special focus on exports market development. Huge business opportunities are expected to emerge during the event. Besides, this year we have launched a Mobile App called iPHEX Mobile App. This APP is a perfect electronic event guide displaying the list of buyers, exhibitors, their speciality, areas of interest etc at just a click.”

“The unique model of exhibition format where each buyer from more than 89 countries meet each and every exhibitor is a model by itself. Due to this model, Pharmexcil has taken a lead to increase the reach of these buyers so that exhibitors can in turn maximize the potential of these buyers and explore new business opportunities,” concluded Mehta.

The next show of PHARMA Pro&Pack Expo 2016 and PharmaLAB Expo 2016 will be held during April 27 to 29, 2016 in Mumbai.

EP News Bureau-Mumbai

EVENT BRIEF JULY -AUGUST 2015 20

2nd Annual Advanced API Convention

2ND ANNUAL ADVANCED API CONVENTION Date: July 20 - 23, 2015 Venue: Mumbai Summary: CPhI 2nd Annual Advanced API Convention will focus on the development of high quality API’s for the Indian pharma market. To counter India’s 90 per cent dependency on China for essential drugs, this conference will focus on quality, technology and cost efficiency in the processes for making the API drugs.

Contact details Phone: +44 (0)20 7921 5000

GLOBAL GREEN NANOTECHNOLOGY CONCLAVE 2015 (GIGANTIC 2015) Date: August 6-7, 2015 Venue: Ahmedabad Summary: The conclave brings together technologists, scientists, academicians, policy makers and end-users of the nanotechnology platform for discussing the various aspects of development and characterisation, exploring the possibilities of Indian industry to take part in nanotechnology research, product development, growth and initiating new ventures through partnerships with foreign players who are leader in the field.

Objectives of the conclave are to provide a platform for researchers and industrialists to interact with each other and share knowledge, create awareness among the endusers and consumers on nanotechnology, to facilitate the technology requirement and other related needs of the industry through national and international networking, to interact with the government to establish policy and

6

Global Green Nanotechnology Conclave 2015

standards for nanotechnology processes, to facilitate the training needs of the start-up companies in nanotechnology field, facilitate knowledge flow by working with international organisations through bi-lateral/multi-lateral cooperation mechanism and discuss scope, challenges and future application of nanotechnology.

Contact details Gaurang Patel Executive Centre of Excellence in Nanotechnology Confederation of Indian Industry, CII House, Gulbai Tekra Road, Near Panchwati Ahmedabad – 380 006 Contact No: 08460464349 Tel. (079) 40279994; Fax. (079) 40279999 Email. Gaurang.patel@cii.in

CPHI INDIA Date: December 1 – 3, 2015 Venue: Bombay Convention and Exhibition Centre, Mumbai Summary: Key decision makers in the pharmaceutical industry from 92 countries, including India, China, the US, the UK, France and Italy will participate. Visitors can meet all major suppliers of pharmaceutical ingredients, outsourcing, equipment and bio-solutions in one location.

P-MEC, ICSE and BioPh will be co-located with CPhI event.

Contact details UBM India Times Square Unit No. 1-2, 5th Floor, ‘B’ Wing, Andheri Kurla Road, Marol Andheri (East) Mumbai – 400 059 Tel.: +91 22 61727272 Fax. +91 22 61727273

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DOP/PAO Leak Testing Air Flow Pattern (Smoke)Test

cover )

Pharma exports grew at just 1.2 per cent in FY 2014. Can the latest Foreign Trade Policy galvanise creation of better infrastructure to boost the growth rate?

BY USHA SHARMA

24 EXPRESS PHARMA July 1-15, 2015

(

T

he Narendra Modi-led NDA government is aggressively working to enhance infrastructure across the country. As part of this mission, the government is building up a system to improve connectivity between remote areas to developed cities and metros for better engagement. To accomplish this, the Department of Commerce, Ministry of Commerce and Industry had included provisions in the recently released Foreign Trade Policy (FTP) 2015-2020, aimed at helping companies set up manufacturing facilities in Jammu and Kashmir, and the Northeastern states.

Learnings from Baddi The new FTP 2015-2020 will give double weightage to one-star export houses, especially for manufacturing units under micro, small and medium enterprises (MSMEs) to promote Jammu and Kashmir, and the Northeastern states. The move indicates that the government is encouraging companies to explore these zones. But as industry experts point out, this strategy could be flawed. As an example they refer to Baddi in Himachal Pradesh, which has a similar terrain, but did not become a success story inspite of similar ‘free zone’ in-

centives.

Talking about the issues in Baddi, Amol Yelgaonkar, Head – Corporate Quality, Bliss GVS Pharma informs, “Baddi has been experiencing a big problem of zero infrastructure (roads, hotels, restaurants, housing) since the inception of this zone. It was only in the last two to three years of its tax holiday period that the new road from Chandigarh to Baddi via Saswan Dam was built.

This should have been done in the first place. Even today, 90 per cent of employees working in pharma companies in Baddi stay either in Chandigarh or Panchkula and spend lot of time in travelling, leading to a high cost of living.”

In 2002, the then Prime Minister, Dr Manmohan Singh, during his visit to Baddi, had announced a tax holiday and central excise concessions to attract investments to Baddi, Himachal Pradesh. He offered 100 per cent outright excise duty exemption for a period of 10 years from the date of commencement of commercial production. And, towards the end of 2003, the central government had announced 10 years' excise and income tax holiday for Himachal Pradesh, Uttarakhand and Jammu & Kashmir. To leverage the opportunities offered, many big pharma

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companies as well as allied industries set up their manufacturing facilities in Baddi.

However, in the later years, the announcement looked unrealistic and ill-informed to both pharma as well as allied industries.

Elaborating on the reasons for Baddi's failure to become a manufacturing hub, Dr SB Rijhwani, Manufacturer and President IPA MP State Branch, Indore explains, “Over capacities created in Himachal Pradesh and Uttarakhand areas resulted in competition and the benefits to be enjoyed by MSMEs were passed on to the buyer. As a result, many units had to close down their manufacturing operations, thus there are many sick units present in these areas.”

Pharma companies are reluctant to consider these zones as preferred destinations for fresh investments.

So, why is the government encouraging companies to set up manufacturing facilities in Jammu & Kashmir, and the Northeastern states, which have almost similar constraints? What have been our learnings from Baddi and what more needs to ensure that we do not emulate Baddi's failure?

SR Vaidya, Director, Bliss GVS Pharma suggests, “The Government should envisage an atmosphere which encourages harmony in these

THE MAIN FOCUS

areas. (It should be done) by providing voice to the participants to build a cohesive roadmap around them.”

There are other issues as well which contribute to the delay in the progress of these states and require special attention from both the State as well as Central government bodies. Yelgaonkar informs, “Infrastructural issues associated with Sikkim and J&K would be the terrain and the geographical location. Second most important factor in J&K will be safety of people as it is still not free from terrorist attacks. Overcoming these will be the responsibility of the State and Central government by providing adequate and good roads, transport and housing including assurance of security.”

In need of a dedicated approach The tax exemption offered in 2003 was restricted to 10 years, from the time approval was given by the governing authority. It was also specified that further extension for any delay in setting up and commencing operations would not be considered. However, due to the lack of talent and infrastructure, companies started facing problems in setting up new manufacturing facilities in Baddi. It is quite possible that history

The Government should envisage an atmosphere which encourages harmony in these areas.

(It should be done) by providing voice to the participants to build a cohesive roadmap around them SR Vaidya Director, Bliss GVS Pharma

The Government has encouraged units in J&K, North East states and Sikkim with attractive incentives, but the major hurdles are very poor infrastructure, lack of trained manpower and accessibility TS Jaishankar Managing Director, Quest Life Sciences

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cover ) Land, labour and power are the three components that local states have to provide easy access to Vinay Pinto Executive Director Wallace Pharmaceuticals

Infrastructural issues associated with Sikkim and J&K would be the terrain and geographical location Amol Yelgaonkar Head – Corporate Quality, Bliss GVS Pharma

Over capacities created in HP and Uttarakhand areas resulted in competition and the benefits to be enjoyed by MSMEs were passed on to the buyer Dr SB Rijhwani Manufacturer and President IPA MP State Branch, Indore

26 EXPRESS PHARMA July 1-15, 2015

may repeat itself in the case of J&K and the Northeastern states if concrete steps to avoid such an occurrence are not implemented on a priority basis. Rijhwani highlights, “The Government had declared incentives for Sikkim, Guwahati, Jammu, Himachal Pradesh and Uttarakhand in 2005 for 10 years, but due to logistic reasons and fear for the safety of employees, manufacturers are still not going to Guwahati, Sikkim and Jammu areas, especially MSMEs and new entrepreneurs.”

Highlighting the critical issues that these industries might face in these locations, TS Jaishankar, Managing Director, Quest Life Sciences avers, “The government have encouraged units in J&K, North East states and Sikkim with attractive incentives, but the major hurdles are very poor infrastructure, lack of trained manpower and accessibility.”

Lack of infrastructure support from the state and the central government have forced companies to move out. As a result of bad connectivity, many pharma companies have opted keep their facilities idle or turn it into a warehouse facility.

Rijhwani informs, “One good thing that’s happened is that most of the big companies have put up distribution godowns and many transport companies have their offices. Also many raw material suppliers have opened their godowns and packing material manufacturers have also put up their plants in Himachal Pradesh and Uttarakhand.

Speaking on the support required from the State governments to tackle the challenges, Vinay Pinto, Executive Director of Wallace Pharmaceuticals says, “Land, labour and power are the three components that local states have to provide easy access to. The local government should bundle tracts of land, set land rates and communicate the same

to industry bodies like IDMA for easy industry selection and decision. From our experience, trained manpower has gradually improved through the development of local pharmacy colleges, technical colleges, etc. Power distribution is often an issue and has to be developed systematically along with development of land.”

Recalling his own experience, Pinto divulges, “Even though power is exported from Himachal Pradesh, we received government power about five months after commissioning our plant in 2007 due to an inadequate power distribution infrastructure.

Local transport unions

fact, the government has been taking initiatives to improve the scenario. At iPhex 2015, a pharma event held in Mumbai, a government official revealed that the Government is ready to offer different schemes to boost Indian pharma exports. He informed that the existing SEZs account for around 40,000 hectares of land which is lying vacant.

The government is trying to revive the sick/non-performing SEZs and the companies within them. The government is putting efforts to revive floundering SEZs as well. It has extended its export inventive schemes for both goods and services to

minimum period of three to five years without insisting on net foreign exchange arranging to be positive.”

Jaishankar also suggests, “Primarily the Government should set up training institutes in IT, diploma in mechanical engineering and skills related to our industry.” He shares few examples of schemes by Tata Institute of Social Sciences (TISS), School of Vocational Education to recruit people in the local areas of J&k, Sikkim, etc. Through this scheme, TISS would undertake training and the workforce recruited would be able to obtain a diploma in vocational education after completing

The latest FTP attempts to improve exports in pharma and create manufacturing hubs within the country. However, unless core issues such as lack of adequate training and poor infrastructural facilities are addressed effectively, the desired impact and progress would continue to elude us caused some initial challenges. But our experience has been generally good.”

Pinto further elaborates, “For better planning, longer time windows for incentives are always preferred. If the objective of the mid policy review is to extend the time period it is good. But if any other terms are changed mid policy, then companies get affected as the expected returns cannot be met as per calculations on which the initial investment decision was made. For instance, most companies invested in Himachal Pradesh and J&K when excise was 16 per cent.

Thereafter excise rates have changed several times.”

Unless these problems are resolved, giving renewed focus to these areas would not have the desired impact.

Taking cognizance of this

units within SEZs as well. It has also been decided that instead of an annual exercise, the government will conduct a mid-policy review after two and a half years.

However, not everyone is convinced about the effectiveness of these measures.

Jaishankar feels, “For export purpose there is hardly any difference between units outside SEZ and inside SEZ. All the benefits of exports are available more or less in the same manner for units outside, such as excise exemption, sales tax, VAT are in any case exempted; but in the case of units in SEZ it takes a minimum of three to five years to register their products in global regulatory markets. Till such time they should be permitted to market in the domestic market without customs duty for a

three years of work in their respective factories. This will certainly enhance assured employees for three years and their skill is monitored by weekend training

by TISS.” Thus, the latest FTP attempts to improve exports in pharma, and create manufacturing hubs within the country. However, unless core issues such as lack of adequate training and poor infrastructural facilities are addressed effectively, the desired impact and progress would continue to elude us.

If the Government really intends to propel growth in pharma exports then it's high time to identify and fill the gaps that are impeding progress with timely measures. u.sharma@expressindia.com

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THE MAIN FOCUS

I N T E R V I E W

'Pharma Zone at RGIA Cargo Terminal has seen steady growth’ SGK Kishore, CEO, GMR Hyderabad International Airport Ltd (GHIAL), talks about the success of the pharma zone at the GMR Hyderabad International Airport and the further measures that would be implemented which would also prove beneficial for the pharma sector, in an interaction with Usha Sharma

In 2011, the GMR Hyderabad International Airport opened India's first airport-based temperature controlled facility. Tell us about its progress since inception.

Pharma Zone at RGIA Cargo Terminal has seen steady growth over the last few years.

The CAGR from 2011 to 2014 has been nine per cent in the volumes handled. We expect this growth to continue in the coming years as more and more pharma exporters are adopting the WHO GMP and GSDP practices to meet the standards in manufacturing and distribution.

How do you manage the pharma zone and what were the challenges in doing so?

The industry took some time to understand and adopt the pharma zone facilities, but with our sustained clear marketing strategy, pharma companies realised the value add. Now the pharma zone is running successfully.

How has your facility helped domestic pharma firms?

With the strict standards being adopted by the pharma industry, it is imperative that the cold chain integrity is maintained throughout the supply chain. To achieve this objective, RGIA built a worldclass dedicated pharma goods handling facility called 'pharma zone'. Domestic pharma companies are utilising our pharma zone to handle their

temperature sensitive cargo.

RGIA has tied up with Envirotainer. How will this help pharma companies?

RGIA was among the first to obtain permission to seamlessly move active-cooled ‘Cool Containers’ to and from the shipper/consignee premises, offering its customers an opportunity to put in place a truly unbroken end to end cold chain. To make this service offering more convenient for the users, RGIA has tied up with Envirotainer, the renowned Swedish maker of such ‘Cool Containers’ to use RGIA as the regional base of operations, offering a ready supply of containers for customers in the region. This unique facility at RGIA will encourage industry players to grow their facilities in the region and cater to the huge export market.

Which services have you introduced at RGIA which may benefit pharma firms? ◗ RGIA boasts of Code-F (A380 type) capable, dedicated cargo apron. Built adjacent to the cargo terminal, the location of cargo apron ensures that shipments are safe from exposure to the elements by minimising the time spent on the tarmac and in shifting pharma cargo to dedicated temperature controlled area. ◗ Another innovation introduced recently relates to the use of environment friendly

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GHIAL is in talks with several leading airlines for introduction of freighter capacity at RGIA

and light-weight ‘slip sheets’ in place of traditional wooden ‘skids’ to stack cargo. The reusable slip sheets do not require any fumigation and minimises avoidable weight and volume onboard flights, resulting in direct reductions in costs and environmental impact. RGIA Cargo Terminal has invested in modern, specialised handling equipment needed to handle the shipments arriving with slip sheets in place of wooden skids, thereby delivering another competitive advantage for its users. ◗ RGIA is also a pioneer in providing an added alternative facility for pharma customers, to be able to ship or receive their goods at a location closer to customers, through opening of air freight stations (AFS) and connections to multiple cities in its catchment areas through Road Feeder Service (RFS).

RGIA is connected with two AFSs at Nagpur and Chennai.

This gives our customers multiple options and helps them improve their supplychain efficiency thereby benefitting the trade, region and the country as a whole. ◗ RGIA hosts India’s first and only airport-based multiproduct FTZ. The fact that the FTZ is inside the airport makes it unique which will help pharma companies bring down the transportation costs, reduce the turnaround time for movement of goods, do value add and increase exports thereby earning precious

foreign exchange.

GHIAL has tie ups with several airlines. Provide an update on the same.

RGIA has the world’s major airlines flying out of RGIA providing wide-body cargo lift.

The Freighter ATMs at RGIA grew by a huge 62 per cent (y-oy) and the airport is connected to most major hubs in both East and West. GHIAL is in talks with several leading airlines for introduction of freighter capacity at RGIA. More capacity will mean that the pharma companies will have direct access to their customer base, reaching them faster thereby reducing transit costs.

How do you ensure that pharma export consignments comply with rules like 2D barcoding before shipping ?

Dept of Commerce & Industries has issued guidelines to pharma companies on the 2D barcoding of export consignments.

Further, at the airport level also, we have our own barcoding system for monitoring of cargo.

Tell us about the company's plans for the current fiscal.

We will continue to grow our international connectivity and expand our cargo network.

Further, we are also exploring the feasibility of adding new infrastructure/facilities within our cargo village. u.sharma@expressindia.com

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cover ) INSIGHT

Robotics in pharmacy automation Automation of clinical laboratories is just the beginning of a new era that has started with the initiation of programmable robots says Dr Ramalatha Marimuthu, Senior Member, Institute of Electrical and Electronics Engineers (IEEE)

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obots in laboratory, life science and pharmaceutical applications perform tasks at rates beyond human capability.

It is hence, definitely essential for robotics to reach out to every area of science and technology and every nook and corner of the world. In the next ten years, the humanoids will be playing an important role in helping school students learn, engineers to create and medical personnel to provide more efficient healthcare. In addition hazardous operations and environments would and should be manned by robots. Though the reach of this technology may be in different levels in different parts of the earth, the impact of robotics has already started to be increasingly known almost everywhere including laboratory automation.

Laboratory automation is a growing field for robotics, from drug discovery to pharma and medical device manufacturing, to performing blood sample testing.

Since clinical laboratories started to use robotic technologies in the early 1980s to administrate their thousands of samples a day, automated systems have become a known thing in the industry. By increasingly and continuously performing procedures that would have been done without them, these modern automated robotic systems can increase the throughput of a laboratory manifold, free up researchers from repetitive tasks and allow them to contribute their time to more con-

28 EXPRESS PHARMA July 1-15, 2015

ceptual and productive work, and monitor and supervise the raw data manufactured.

Pharma companies engage such robots to passage biological or chemical trials around to create new chemical products or to test pharmaceutical value of existing chemical materials.

Due to the potential hazards and high volumes, some hospitals and larger healthcare clinics utilise robotics to dispense medication. Thanks to technology, these innovations have come into important roles in potentially dangerous surroundings that may be in close proximity to biological hazards, or at situations where immediate action is required for patients. Robotic pharmacies are expanding rapidly within hospitals and clinics. Robotics has thereby resorted to assemble and package an array of medical functions as well as performing a number of automated procedures like conducting blood tests, X-rays, providing first aid in ambulance cars, etc. Several companies are servicing that market and the interest level will only increase.

It all translates to whether the robotic machines can be adjusted to a series of motions and movements based on inputs fed to them in advance, for example, the specific amount of rays that should be passed to the human and carry on to the placing of film and so on, extended to- placing a film if a person is there, to identify as soon as the plate is filled and switch on the machine, find out if X-ray has been done and finally remove the film and

Due to the potential hazards and high volumes, some hospitals and larger healthcare clinics utilise robotics to dispense medication process it.

For any of the robot connected work in such automated lab scenarios, monitoring system is a random check.

Whether it is possible for them to use human cognisance depends on the adjustment on their position. So the inputs have to be fed in. For example, while discussing the feasibility of robots in conducting X-rays, with the help of systems that can study and then feed inputs, these machines can be used to move chair and positions, correct positions of leg and toe can be identified to build an overall control system and rest can be controlled by the machine itself.

Advanced robotics can also be used to completely automate the process of science in laboratories. For example, in pharma applications, hospitals use robots to fuse dangerous

cancer drugs and those related with radioactivity. Because of the high number of samples that need analysis and the amount of data collection required, the process and costs are easily authenticated with robotics. Similar to its applications of performing blood tests and X-rays, robotics can be used to connect all of this together and provide assistance in ambulance cars as well where quick action and first aid is considered very important.

Essentially, all the manual activity of handling the equipment and doing the work defined by standard procedures can be performed automatically, allowing humans to invest their time in more cognitive jobs. One of the advantages to such automation procedures is faster processing (though not necessarily faster than a human operator).

Typically, robotics and automation in such laboratories contribute towards productivity, as machines are not likely to get redundant due to routine procedures and hence lack in quality and efficiency. Human constraints, such as speed, too are eliminated as a reason to worry about as robots can work continuously without the possibility of experiencing boredom and hence being subject to carelessness or irresponsibility.

However, the entire process of automation can turn out to be expensive as the costs of a sample assessment and motion study can be high in itself, let alone the maintenance needed for these robotic machines.

DR RAMALATHA MARIMUTHU, Senior Member, Institute of Electrical and Electronics Engineers (IEEE)

There are a few techniques that haven’t been automated yet.

Automation of clinical laboratories is just the beginning of a new era that has started with the initiation of programmable robots, which can be fed the inputs and expected to deliver the desired outputs systematically. The decades to come will witness certain remarkable developments in laboratory automation and integration with the help of robotic technologies that will indeed enhance the efficiency and bring down the costs of laboratory testing. Although robotic technology has been in place in the laboratory setting for over two decades, it represents moderately fresh technology as compared to the clinical laboratory setups in the 1990s that would just consist of automated sample delivery, coding, processing, analysis, and reporting.

Robotics now, not just has emerged as a novel and advanced field in pharmacy automation but also has gained much known admiration in the industry. Their applicability in different fields of pharma industry is appreciated. It is accepted that in future the robotics would play a vital role for the development and growth of pharma sciences. With a history of over two decades, the technology once confined to clinical laboratories, robotic machines have found their way into the testing with the insatiable demands of the pharma industry that are helping to drive labs into the automated world of industrial production lines.

MANAGEMENT ROUND TABLE

FTP 2015-2020

Awelcome move The Ministry of Commerce, Government of India has released the new Foreign Trade Policy for 2015-2020, to be amended from June 30, 2015. Industry stakeholders analyse its impact on the pharmaceutical sector

BY USHA SHARMA

'2015-2020 FTP DEMONSTRATES THE WISDOM DAWNING IN INDIATO HANDLE GLOBAL CHALLENGES WITH MATURE AND ERUDITE LEADERSHIP' DR GOPAKUMAR G. NAIR, Gopakumar Nair Associates

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uccessive trade policies from 1960’s to 2015 had moved through import export policies based on negative lists, red books and green books mostly driven by procedural provisions managed through import and advance licences and a plethora of incentives, like duty drawbacks, cash compensatory supports etc. The Foreign Trade Policy (FTP) is a welcome floribunda with deep insight into global economy and domestic challenges along with region wise and country wise SWOT analysis. Market strategy for specific markets has been elaborately dealt

with highlighting opportunities and challenges. Pharmaceuticals have been dealt with under ‘product strategy.’ While generic drug opportunities have been highlighted, the NTBs (Non Tariff Barriers) which block entry and trade opportunities in markets such as China and Japan have also been dealt with. The challenges facing pharma sector has been listed out.

IPR status, PIC/PICS (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) non-membership status, alleged quality compliance issues, impact of stiff domestic pricing on over-

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MANAGEMENT seas price realisations etc. have also been acknowledged. The FTP has analysed the current status of WTO (World Trade Organization), TRIPs (Agreement on Trade-Related Aspects of Intellectual Property Rights) and other WTO based agreements, more importantly, the potential impact of TPP (Trans-Pacific Partnership), TTIP (Transatlantic Trade and Investment Partnership) and RCEP (Regional Comprehensive Economic Partnership) along with RTAs (Regional Trade Agreements), FTAs

(Free Trade Agreements), PTAs (Preferential Trade Agreements), CECAs (Comprehensive Economic Cooperation Agreements), CEPAs (Comprehensive Economic Partnership Agreements) have been discussed and elaborated with consequent impacts on India’s exports. Need for PIC/PICs membership or observer status by India has been emphasised. India is facing formidable challenges in these TBTs (Technical Barriers to Trade) and NTBs which need to be overcome by pragmatic

T

he First Foreign Trade Policy (201520) of NDA Government was unveiled

by Commerce Minister Nirmala Sitharaman on April 1, 2015. The policy lays down a road map for Indian global engagement in coming years, targets 15 per cent increase in exports on annual basis and has a thrust on ‘Make in India’, ‘Digitisation’ and ‘Ease to do Business’. The new Foreign Trade Policy (FTP) has been announced in the back drop of dip in exports because of moderation in demand globally. New FTP has merged all incentive schemes under Chapter 3 into Merchandise Exports from India Scheme (MEIS) and Services Exports from India Scheme (SEIS). The benefit under MIES will be determined based on exporting product and exporting country divided in various groups. The benefit will range between two to five per cent of FOB Value of Exports. Classification up to eight digit for the export product is very important for claiming the benefit under this scheme. Exporters need to understand the significant of the product classification.

Served From India Scheme (SFIS) is being replaced by a New Scheme - Services Export from India Scheme (SEIS). All service providers of notified services located in India will be eligible for the benefits regardless of their constitution or profile of service provider. The SEIS benefit of three per cent

30 EXPRESS PHARMA July 1-15, 2015

review and action plan, according to the FTP. In depth analysis of constraints incorporated into the FTP, is heartening to note. Major constraints being those of infrastructure, logistics, ease of doing business, digitalisation, e-governance and border management. In the light of extremely adverse remarks in the recent USTR 2015 Report on bulk imports of pharma APIs from China to India circumventing regulatory systems, by labelling APIs as chemicals, additional IPR burden need to be

'THIS IS A GOOD POLICYAND PEOPLE WILL BENEFITTHE MOST,IF IT IS IMPLEMENTED EFFECTIVELY' AJIT J SHAH, Faculty & Trainer in Export & Import

or five per cent will be based on Net Foreign Exchange Earned.

This scheme aims to explore the huge opportunities of rendering our services to the rest of the world. Skill India is also on the agenda of the present government.

The duty credit scrip issued under both MEIS and SEIS will without any actual user condition, freely transferable. They will be no longer restricted for any specified types of goods.

They can be used for payment of customs duty /excise duty/service tax. These scrip can also be utilised to make the payment against excess import under advance authorisation.

The multiple usage of the scrip will increase the demand and supply of the scrip in the market. Since, the percentage of

benefit is reduced, the value available in the market may not substantially enhance. However, the volume of trading in the scrip will increase.

The units in SEZ will also be allowed to claim incentive under MIES and SIES Schemes.

The nomenclature of status holder scheme has been changed to one, two, three, four and five star export house. The criteria for export performance for the recognition of status holder have been changed from Rupees to US dollar. The minimum export performance in FOB Value during current and previous two years is now $3 million. All the existing status holders are instructed to make a fresh application as per this revised norms on or before June 30, 2015.

realised on border management by customs authorities but also the regulatory authorities. It is also heartening to note that FTP notes the need for reduction in transaction costs.

While consolidation and simplification of incentive schemes and extension to SEZs (Special Economic Zones) are welcome features, the highlights of the FTP is the economic analysis and SWOT analysis demonstrating high potential to address international trade issues facing India.

Unlike earlier Trade Policies, the 2015-2020 Foreign Trade Policy demonstrates the wisdom dawning in India to handle global challenges with mature and erudite leadership.

More deliberations for convincing the domestic audience on the need to target global benchmarks in regulatory framework, trade regulations and emerging bilateral, regional and multilateral trade partnerships and agreements need to be undertaken using the FTP as a reference standard.

Manufacturer Status Holders will now enabled to self certify country of origin from India to qualify under various PTA, FTA, CECAs and CEPAs. To boost ‘Make in India’ specific export obligation under EPCG will be reduced to 75 per cent, if goods are procured from domestic capital goods manufacturer.

Hard copies of CA /CE /CS certificates will not be required for various applications. Online upload facility of its soft copy will be made available in the new online application process for Chapter 3 and Chapter 4 Schemes.

Document records of EPCG authorisation will now be required to be maintained only for two years after redemption.

A facility has been created to upload documents in exporter importer profile, which will hold copies of IEC, PAN, RCMC, industrial License etc.

Once uploaded, no separate submission of these copies will be required with each application.

Communication with exporter/importer will be done through SMS/email and thus mandatory fields like mobile number and email address will be added in the IEC data base.

Application of refund of terminal excise duty will now be made online.

EOUs, EHTPs, STPs have now been allowed to share infrastructural facilities among themselves, inter unit transfer of goods and services and to set up facility of warehouses near

the port of export. Goods falling in the category of handloom products, books/periodicals, leather footwear, toys and customised fashion garments, having FOB Value upto `25,000 per Consignment (finalised using e-commerce platform) shall be eligible for benefits under FTP. E-commerce exports will allowed to be done under manual mode through foreign post offices at New Delhi, Mumbai and Chennai and under courier regulations through Airports at Delhi, Mumbai and Chennai Only.

Chapter number 8 is incorporated in the policy, to resolve quality complaints and trade disputes. A Committee on Quality Complaints and Trade Disputes (CQCTD) is being constituted. Vishakhapatnam and Bhimavaram in Andhra Pradesh are to be recognised as towns of export excellence for product category - Seafood.

It can be noted that specific application, procedures and documentation will have to be prepared, applied and submitted as defined under the New FTP and handbook of procedures to avail of any of the said benefits under the new FTP. In conclusion, we can say that this policy is prepared by considering several aspects of the trade. Several circulars and public notices are now forming a part of the policy/handbook.

This is a good policy and people will benefit the most, if it is implemented effectively. u.sharma@expressindia.com

MANAGEMENT I N T E R V I E W

‘Significant improvements have occurred in medicine quality in Asia’ The US Pharmacopeial Convention (USP), recently brought together national medicines control laboratory officials for a workshop in Hyderabad at its India office on improving aspects of medicines quality in the Asia-Pacific region. Kelly Willis, Senior Vice-President Global Public Health, US Pharmacopeia shares the details in an interview with Shalini Gupta

How many national medicines control laboratory officials came for the workshop and which countries did they represent? How many times has this meeting been organised before and what have been the achievements so far?

Representatives from eight National Quality Control Laboratories from seven countries including Laos, Myanmar, Cambodia, Vietnam, Philippines, Thailand, and Indonesia attended the workshop along with Dr GN Singh, Director General, DCG(I), Director of the Central Drug Testing Laboratory of Telangana as well as representatives of the Indian Pharmacopeial Commission and Pharmexcil.

This is the second NOMCoL meeting in South East Asia. The first meeting was held in February 2013 in Siem Reap Cambodia. So far the NOMCoL initiative has led to increased capacity of the national quality control laboratories to conduct compendia testing, improved mechanisms for sharing information as well as development of a framework for collaborative testing to identify gaps in the quality assurance systems in the countries.

Which areas did you focus upon in this meeting?

At the workshop, we introduced national quality

control laboratories in the region to our facility at USPIndia and established mechanisms for increased collaboration between the countries in the Asia-Pacific region and USP-India. We also developed a shared framework for the collaborative testing of medicines in the region and identified priority medicines of interest for collaborative testing. Most of the laboratories in these countries have been instrumental to providing confirmatory test results to the Promoting the Quality of Medicine’s (PQM) BREMERE initiative, which investigates poor quality medicines in Southeast Asia.

Promoting the Quality of Medicines (PQM) established the Regional Expertise in Medicines Regulation, Information Sharing, Joint investigation and Enforcement (BREMERE) initiative to enhance the timely information-sharing and cooperative action on the quality of suspected, falsified, counterfeit, and substandard medicines among regulators and partners in the region, and beyond, to facilitate enforcement actions. PQM is a collaborative agreement between the US Agency for International Development (USAID) and USP. Which laboratories in Asia

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We are applying current known technologies in smarter ways to better solve the problems of counterfeit and substandard medicines

Pacific in particular are doing well to promote safe medicines? What work are they doing in particular?

Which countries do they represent? What have been some of the learnings?

Many countries in the region have made good progress in building a good capacity for quality control of medicines.

Countries that stand out in this regard are Vietnam and Thailand. They both have attained ISO 17025 accredited laboratories and are helping to strengthen laboratory capacity in other countries in the region.

These two laboratories have also achieved WHO Prequalification with the assistance of PQM. Having attained both ISO accreditation and World Health Organisation (WHO) prequalification status, these NQCLs can serve as a reference for pharmaceutical manufacturers in the region that are seeking to supply bulk medicines to procurement agencies but must first obtain WHO product prequalification to ensure that their products meet acceptable standards of quality, safety and efficacy.

problem of substandard and counterfeit medicines still persists, it has improved. For example, in 2003, Cambodia had an alarming rate of upto 40 per cent for substandard and counterfeit medicines, but today, given these improvements, that number is much smaller.

How would you rate the quality of medicines in the Asia Pacific? Which countries stand apart and why?

Significant improvements have occurred in medicine quality in Asia. While the

What are some of the novel strategies and tools for increased data transparency and information sharing with laboratories?

These include increased collaboration, coordination,

What have been some of the newer methods for analysing the quality of drug samples and increase laboratory performance that you aim to bring to India with this workshop?

The methods of analysis are not so much what are new; what is new, and smarter, it is how we are applying existing technologies. We are applying current known technologies in smarter ways to better solve the problems of counterfeit and substandard medicines. For example, we are promoting the use of field based screening technologies such as Raman spectrometry to quickly screen medicines in the field especially in remote parts of a given country so that poor quality medicines can be quickly removed from the supply chain.

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MANAGEMENT communication and sharing of test results and other relevant information on specific cases of suspected products found in the region.

They are discussing plans to develop an online information and data sharing platform for the NOMCoL Asia Pacific lab members. All countries represented at this workshop have functional quality control laboratories and are all in the front line of their countries to control the quality of medicines in the respective countries.

At the workshop, USP experts shared current approaches for conducting quality control and stressed the need for proper quality management systems to ensure data integrity and reliability.

32 EXPRESS PHARMA July 1-15, 2015

All countries represented at this workshop have functional quality control laboratories and are all in the front line of their countries to control the quality of medicines in the respective countries. At the workshop, USP experts shared current approaches for conducting quality control and stressed the need for proper quality management systems to ensure data integrity and reliability How do you think regulatory authorities can partner better with USP to achieve a standardisation of laboratory practices and better sharing of best practices?

Regulatory authorities play a central role in ensuring that quality standards are adhered to. In general standards are not embraced without regulatory oversight, hence regulatory authorities

play a principal role in ensuring compliance. USP seeks partnership with regulators in a number of ways including working through NOMCOL where USP shares best practices in

quality control, through our RSAP (Reference Standard Assistance Program) where we make primary reference standards and documentary standards available to countries at reduced or no cost to allow them to use high quality and reliable reference materials. Through these programmes, USP hopes to foster strong quality management culture in the quality control Laboratories so that results produced are reliable and trustworthy. We also support exchange programmes through visiting scientist programmes and international technical assistance programme at USP-US in the US to share learnings and best practices. shalini.g@expressindia.com

RESEARCH CLINICAL UPDATE

Boehringer Ingelheim announces OS results from LUX-Lung 8 trial at ASCO 2015 The results of LUX-Lung 8 are very encouraging because they illustrate the clinical relevance of targeting ErbB receptors in this disease BOEHRINGER Ingelheim announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy.

Treatment with afatinib significantly reduced the risk of death by 19 per cent, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. Significantly more patients treated with afatinib were still alive at one year compared to those treated with erlotinib (36.4 vs 28.2 per cent). The details of the OS analysis were presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US. The complete results from the study will be the basis for global regulatory submissions later this year. Afatinib is not approved for use in patients with SCC of the lung.

OS was the key secondary endpoint of this randomised phase III head-to-head trial, and was analysed following positive results for the primary endpoint of progressionfree survival (PFS) presented in 2014. The updated analysis of PFS confirmed a significant reduction in the risk of cancer progression by 19 per cent in patients treated with afatinib compared with erlotinib. The delay in cancer progression seen with afatinib treatment

was accompanied by improved control of cancer-related symptoms: a higher proportion of patients treated with afatinib reported improvement in cough (43.4 vs 35.2 per cent), shortness of breath (51.3 vs 44.1 per cent) and overall well-being/quality of life (35.7 vs 28.3 per cent) compared with erlotinib.

LUX-Lung 8 clinical trial investigator Professor Jean Charles Soria, Head Drug Development Department, Gustave Roussy Cancer Centre, Paris, France commented, “Squamous cell lung cancer is a difficult-totreat disease with extensive comorbidities, and patients would benefit from more treatment options. The results of LUX-Lung 8 are very encouraging because they illustrate the clinical relevance of targeting ErbB receptors in this disease. International guidelines recognise erlotinib as a second-line treatment option for squamous cell carcinoma of the lung, and improved outcomes

demonstrated with afatinib suggest this treatment could offer additional benefits for this patient population.”

The rate of severe adverse events was similar between afatinib and erlotinib treatment arms (57.1 vs 57.5 per cent). A higher incidence of severe diarrhoea and stomatitis (mouth sores) was observed with afatinib compared to erlotinib (grade 3/4 diarrhoea: 9.9/0.5 vs 2.3/0.3 per cent, grade 3 stomatitis: 4.1 vs 0.0 per cent), while a higher incidence of severe rash/acne was reported with

erlotinib compared to afatinib (grade 3 rash/acne: 10.4 vs 5.9 per cent).

Dr Mehdi Shahidi, Medical Head, Solid Tumour Oncology, Boehringer Ingelheim, commented, “Following the approval of afatinib in more than 50 countries for the treatment of specific types of EGFR mutation-positive lung cancer and positive overall survival data in patients with the most common EGFR mutation, we are proud to present another piece of evidence for afatinib showing it can prolong survival of patients with squamous cell lung cancer. At Boehringer Ingelheim, we are committed to research and development in areas of high unmet need such as this. It is our goal that afatinib can become a new treatment option for these cancer patients in the near future.”

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer comprising over 85 per cent of lung

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer comprising over 85 per cent of lung cancer cases. SCC, a type of lung cancer which develops in the cells lining the airways, represents approximately 30 per cent of NSCLC cases

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cancer cases. SCC, a type of lung cancer which develops in the cells lining the airways, represents approximately 30 per cent of NSCLC cases.

Treatment options are limited and SCC of the lung is associated with a poor prognosis, with less than five per cent of patients with advanced SCC surviving for five years or longer.

LUX-Lung 8 was conducted across 23 countries and is the first prospective trial to compare two different tyrosine kinase inhibitors (TKIs) in patients with advanced SCC of the lung (n=795).

Afatinib is approved in more than 50 countries for the first-line treatment of distinct types of EGFR mutation-positive NSCLC (under the brand names: GIOTRIF/ GILOTRIF). Approval of afatinib in this indication was based on the primary endpoint of PFS from the LUXLung 3 clinical trial where afatinib significantly delayed tumour growth when compared to standard chemotherapy. In addition, afatinib is the first treatment to show an OS benefit for patients with specific types of EGFR mutation-positive NSCLC compared to chemotherapy. A significant OS benefit was demonstrated independently in the LUX-Lung 3 and 6 trials for patients with the most common EGFR mutation (exon 19 deletions; del19) compared to chemotherapy.

EP News Bureau-Mumbai

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RESEARCH RESEARCH UPDATES

BioMarin’s dwarfism drug improves growth in a mid-stage study The drug, BMN 111 (vosoritide), was evaluated in children with achondroplasia BIOMARIN Pharmaceutical said its experimental drug was effective in improving growth in children with the most common form of dwarfism in a mid-stage study.

The drug, BMN 111 (vosoritide), was evaluated in children with achondroplasia, the most common form of dwarfism, BioMarin said. The company said 10 children receiving the highest dose of 15 micrograms per kilogram of the injectable drug a day showed a 50 per cent increase in their growth velocity, compared with their annualised prior six-month natural baseline growth velocity. “This increase in growth velocity, if maintained, could allow children with achondroplasia to resume a normalised growth rate,” said Wolfgang Dummer, Senior VP, clinical development, BioMarin Pharmaceutical.

All 26 children with an av-

erage age of 7.8 years showed a favourable safety profile, the company said. Vosoritide has an orphan drug status in the US and Europe. The status gives a developer several incentives including a sevenyear market exclusivity in the US and 10-year exclusivity in the Europe. The drug if approved could rake in sales of about $700 million worldwide, Raluca Pancratov of SunTrust Robinson Humphrey wrote in a note to clients.

Achondroplasia is a genetic disorder that affects about 1 in 15,000-40,000 newborns. It is a form of shortlimbed dwarfism. Average adult height for men with achondroplasia is 131 cm (4ft 3 in) and for women 124 cm (4 ft). BioMarin's pipeline includes five approved drugs for the treatment of various rare diseases.

Reuters

Amgen’s cancer drug meets main goal in late-stage study AMGEN SAID its drug met the main goal of improving overall survival in metastatic colorectal cancer patients who have not responded to chemotherapy. The late-stage study was testing the drug, Vectibix, in combination with best supportive care (BSC), compared with BSC alone.

Patients who received 6 mg/kg of the drug every 14 days and BSC showed an improvement in survival rate, compared with BSC alone, the company said. The US Food and Drug Administration approved Vectibix in 2006 as a standalone treatment for metastatic colorectal cancer. In 2014, the drug was approved to be used, along with chemotherapy drug Folfox, as a first-line treatment for a form of metastatic colorectal cancer. In metastatic colorectal cancer, the diseased cells break away from the colon or rectum and spread to form tumors on other organs.

Colorectal cancer affects about 1.2 million people worldwide each year, Amgen said.

Reuters

New drug compound may beat malaria with single $1 dose Finding new medicines for malaria is particularly important because of rising resistance to even the best existing treatments SCIENTISTS HAVE discovered a new anti-malarial compound that could treat patients with a single $1 dose, including those with strains of the mosquitoborne disease that are resistant to current drugs. Although it is still years from reaching the market, results from tests conducted on human blood in the laboratory and in live mice suggest it is highly potent, researchers reported in the journal Nature.

In a vote of confidence for the project, German drugmaker Merck has secured the right to

34 EXPRESS PHARMA July 1-15, 2015

develop and commercialise the compound, assuming it succeeds in further tests. The plan is to advance the experimental medicine into clinical trials within the next year to assess its safety and see just how well it can fight malaria in the human body. Many drugs fall down at this stage in development.

Finding new medicines for malaria is particularly important because of rising resistance to even the best existing treatments. Researchers recently reported that malaria with total re-

German drugmaker Merck has secured the right to develop and commercialise the compound

sistance to the drug artemisinin had taken hold in Myanmar and spread close to the Indian border.

Encouragingly, the new compound works in a different way from other drugs by targeting part of the machinery that makes proteins within the parasite, which means it should be effective against current drug-resistant disease.

Known as DDD107498, it was developed by the University of Dundee’s Drug Discovery Unit and the non-profit Medicines for Malaria Venture. The scientists

behind the project estimate it should cost about $1 per treatment. While there have been significant reductions in the numbers of people falling ill and dying from malaria, it still kills around 600,000 a year - most of them children in the poorest parts of sub-Saharan Africa. Drug companies making existing malaria drugs include Novartis and Sanofi, both of which have special program in place to make their products more affordable.

Reuters

RESEARCH

Avalanche eye therapy meets safety goal; vision improvement modest The medicine is injected into the lower retina, instead of into the vitreous fluid AVALANCHE BIOTECHNOLOGIES’ experimental gene therapy for a leading cause of blindness met its primary safety goal in a small midstage trial, while staving off vision loss.

The product, called AVA101, was well tolerated and was not associated with any serious adverse events in the 12-month study involving patients with the age-related ‘wet’ form of macular degeneration, the company said.

The medicine is injected into the lower retina, instead of into the vitreous fluid, the mode of delivery used for existing treatments such as Roche Holding AG's Lucentis and Regeneron's Eylea. Like those treatments, the Avalanche product is meant to stem the

A larger percentage of patients who received AVA-101 maintained stable vision proliferation of blood vessels in the eye that leak and damage vision. All subjects in the 32-patient study received prior treatment with Lucentis (ranibizumab). Those who then received the Avalanche drug on average gained 2.2 letters on an

eye chart, while those who did not saw their vision decrease by 9.3 letters.

While the 11.5-letter difference was deemed to be significant, patients in earlier studies of Eylea and Lucentis tended to experience greater vision im-

provement. A larger percentage of patients who received AVA-101 maintained stable vision, while more patients in the control group required rescue therapy with Lucentis, the company said. The treatments work by blocking a protein called VEGF. Avalanche's AVA-101 inserts a gene that creates an anti-VEGF protein and keeps producing it, while Lucentis and Eylea are injections of an anti-VEGF protein itself. AVA101 need only be given once, unlike Lucentis and Eylea, which require frequent injections.

Avalanche and Regeneron last year forged an agreement under which Regeneron has a time-limited right of first negotiation to certain rights to AVA-101.

Reuters

and several large drugmakers are now buying into the field.

The medical approach has the potential to revolutionize a number of diseases caused by faulty genes, ranging from blood disorders to eye problems to heart failure. But producing gene therapy products is extremely complex and the $1 million price tag for the first such drug approved in Europe, from Dutch firm UniQure, highlights the quandary facing governments and insurers as to whether they will offer value for money.

40 PER CENT of patients, most with a particularly aggressive form of leukemia, responded to an experimental Agios Pharmaceuticals drug, including several who experienced complete remission, according to data presented. New data from the ongoing Phase I clinical trial appears to confirm the early promise seen with the Agios drug, AG-221.

“There’s nothing (in the updated data) that tells me this isn't going to still become the standard of care,” said Cowen and Co analyst Eric Schmidt. “It’s very clear that a lot of patients are getting a lot of benefit and this drug's better than anything else for these patients.”

Patients in the study either had the bone marrow cancer acute myelogenous leukemia (AML), or the pre-leukemic blood disorder myelodysplastic syndrome (MDS).

Among 63 patients who responded to the treatment out of 158 who were evaluated, 26 (16 per cent) had no sign of cancer in the bone marrow and a return to normal blood cell counts.

Another three were in remission without recovery of normal platelet count, while 16 more had also cleared leukemia from bone marrow without full restoration of other types of blood cells, such as infectionfighting neutrophils. 40 per cent response "is remarkably exciting in this kind of patient population," said Dr Eytan Stein, from Memorial Sloan Kettering Cancer Center in New York, who presented the data at the European Hematology Association meeting in Vienna.

Reuters

Reuters

Bluebird Bio’s sickle cell gene therapy working for French boy Gene therapy is currently undergoing a renaissance following a series of setbacks in the late 1990s and early 2000s A PIONEERING gene therapy for sickle cell disease is working well so far for a 13year-old French boy with the hereditary blood disorder, researchers said, in a boost for the technology to fix faulty genes. He is the first patient with severe sickle cell disease (SCD) to be treated with Bluebird Bio's LentiGlobin BB305 product, which the US biotech company believes could cure the disorder.

SCD is caused by a mutated gene, resulting in abnormal red blood cell function. Patients suffer anemia, painful obstruction of blood vessels and, in

some cases, early death. Bluebird's gene therapy treats the condition by extracting blood stem cells and then adding a working version of the malfunctioning gene. Results presented at the European Hematology Association meeting in Vienna showed the French patient has not needed a life-sustaining blood transfusion for more than three months and his body was producing 45 per cent so-called anti-sickling hemoglobin at six months. "(This) is cause for optimism as we expect levels of anti-sickling hemoglobin of 30 per cent or more could signifi-

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cantly improve and potentially eliminate the serious and lifethreatening complications associated with sickle cell disease,” said lead investigator Marina Cavazzana of Paris Descartes University. Two other patients with a related blood disorder called beta-thalassemia remained transfusion-independent at 16 and 14 months respectively. Bluebird had already reported success with beta-thalassemia patients for a shorter period of time.

Gene therapy is currently undergoing a renaissance following a series of setbacks in the late 1990s and early 2000s,

Agios leukemia drug demonstrates impressive response rate: Study

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RESEARCH

FDAapproves mid-stage trial of vaccine to reverse type 1 diabetes Some diabetes specialists are skeptical about its potential to reverse diabetes DIABETES researchers are hoping that an almost century-old vaccine for preventing tuberculosis may also reverse type 1 diabetes. The FDA has approved a midstage trial to test the vaccine, called bacillus CalmetteGuerin (BCG), in 150 adults with advanced cases of the disease.

The approval was announced at the 75th Scientific Sessions of the American Diabetes Association by Dr Denise Faustman, director of the Massachusetts General Hospital Immunobiology Laboratory in Boston and principal investigator of the study.

According to the American Diabetes Association, five per cent of people with diabetes or roughly three million individuals - have type 1, in which the immune system attacks and destroys insulin-producing beta cells in the pancreas.

Faustman said that the

BCG vaccine temporarily raises levels of a substance called tumor necrosis factor, or TNF – and the higher TNF levels can eliminate the damaging T cells in the blood of individuals with type 1 diabetes.

In a small preliminary trial, Faustman’s team found that two BCG injections given four weeks apart temporarily eliminated diabetes-causing T cells. Patients also showed evidence of small, temporary return of insulin secretion.

This summer, she and her colleagues will begin enrolling patients ages 18 to 60 in a larger five-year trial. Participants will have low but detectable levels of insulin secretion from the pancreas.

They'll receive two injections, four weeks apart, of either BCG or placebo, and then annual injections for the next four years. If this trial is successful, the next step would be an even larger study in a

The BCG vaccine was first used in humans in 1921 as a vaccine against tuberculosis

greater number of patients.

"In the phase I (preliminary) trial we demonstrated a statistically significant response to BCG, but our goal in (this trial) is to create a lasting therapeutic response," Faustman said. "We will be working again with people who have had type 1 diabetes for many years. This is not a prevention trial; instead, we are trying to create a regimen that will treat even advanced disease.”

The BCG vaccine was first used in humans in 1921 as a vaccine against tuberculosis.

More recently, its most common use in the US has been in the treatment of bladder cancer. “It’s a drug with an impeccable safety record,” Faustman said, noting that it has more than 90 years of clinical use and safety data.

Some diabetes specialists are skeptical about its potential to reverse diabetes, how-

ever. Robert Sobel, an assistant professor of endocrinology at Northwestern University’s Feinberg School of Medicine, says everyone working in diabetes is rooting for big discoveries, but he believes prevention will likely come before cure.

“I think it’s a stretch to say this would have a huge impact on the millions plus type I diabetes patients in this country,” Sobel said. “We would love to do something to preserve or repopulate their beta cell mass. Historically, we have watched it dwindle and have not been able to do something (in time).”

“Even people who have challenges with the science, they are certainly hoping that this works,” said Dr Sethu Reddy, chief of the Adult Diabetes Section at Joslin Diabetes Center in Boston.

Reuters

Diabetes pill may lower risk of eye disease in elderly Metformin, a pill that lowers blood sugar in people with diabetes, might also reduce their risk of developing glaucoma, an eye disease that can lead to vision loss and blindness, a new study suggests.

While the results can’t prove the drug prevents glaucoma, researchers found that diabetics taking higher doses of metformin were less likely to develop the eye disease than those who used smaller doses or didn’t take the pill at all. Because metformin has worse side effects at higher doses, more research is needed to better understand whether patients might benefit from taking more medicine just to ward

36 EXPRESS PHARMA July 1-15, 2015

The current study focused on the most common variation, known as open-angle glaucoma off glaucoma, said senior study author Julia Richards, director of the glaucoma research center at the University of Michigan in Ann Arbor Most of these people have type 2 diabetes, which is associated with obesity and aging and occurs when the body can’t make or use enough of the hormone insulin to convert blood sugar into energy. Metformin

lowers blood sugar by preventing the liver from making excess glucose and by making muscle and fat cells better at using available insulin. Glaucoma is group of eye conditions that can damage the optic nerve, typically because pressure builds up inside the eye.

The current study focused on the most common variation, known as open-angle glau-

coma, which starts with gradual loss of peripheral vision.

Richards and colleagues reviewed a database with a decade of health claims and prescription data for 40 million patients. They focused their analysis on a subset of about 150,000 people with diabetes who also had multiple eye exams to screen for glaucoma. At the start of the study period in 2001, all of the patients were at least 40 years old and roughly half were 55 or older. Most of them were white.

Over the course of the study, about 6,000 people, or 4 per cent of participants, developed glaucoma. Patients over age 65 were three times more likely to

be diagnosed with glaucoma than the youngest participants, aged 40 to 45. After adjusting for age and other variables, the researchers found that people who took the equivalent of more than 1.5 grams of metformin a day for two years were 25 percent less likely to develop glaucoma.

Because the study reviewed insurance claims instead of randomly assigning some people to take the drug while another group got no treatment, the findings can’t prove metformin prevents glaucoma, the authors acknowledge in the journal JAMA Ophthalmology.

Reuters

PHARMA ALLY I N T E R V I E W

'We will continue to bring in latest technology to India and help enhance safety and security' Fire safety is an important aspect as it helps to save lives, improve businesses and protect people where they live and work. Tyco Integrated Fire and Security offers advance fire safety solutions and evaluates each of its clients’ specific requirements, and then help them integrate a seamless fire and security system at their organisations. Gopinath K, General Manager, Tyco Integrated Fire and Security informs more about the company’s solutions to Usha Sharma

Tell us about the core competencies of Tyco.

Tyco is dedicated to advancing fire safety and security by finding innovative ways to save lives, improve businesses and protect people where they live and work. With global reach and local expertise, we sell, design, install and maintain integrated systems to detect intrusion, control access and react to movement, fire, smoke, flooding, environmental conditions, industrial processes and other hazards. We also provide retail solutions which can be integrated with our fire and security systems. In India, we serve our customers by offering value-added services and localised solutions through our expertise in the Indian security and fire landscape.

Our solutions can help commercial organisations safeguard against internal and external security threats including fire, burglary, internal theft, intrusion, organised crime, inventory loss, fleet mismanagement and workplace violence. We help protect employees, customers, facilities, assets, inventory, processes and operations with solutions that are geared to meet latest business needs, scaled to enterprise growth, and enhanced with the most

intelligent information management, fire and security management solutions.

The company specialises in offering advancing fire safety and security by finding innovative ways to save lives, improve businesses and protect people where they live and work. How much of this is followed by other pharma companies?

Tyco offers the most advanced methods for securing pharmaceuticals at every point.

We understand what is at stake in pharma security. The risks of financial loss are among the highest in any industry. A breach at any point in the chain can have devastating results on patients’ health. Because of their small size and huge value, combined with a robust black market, pharma are a highreward prize for both petty thieves and organised crime. A single heist can net millions of dollars. Even worse, many drugs are sold back to legitimate pharmacies, which can put spoiled medicines into the hands of consumers.

Pharma safety can be compromised at many points with theft possibilities at any point in the supply and distribution chain — from manufacturing to pharmacy

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Tyco brings more than a century of expertise helping to protect access to buildings, cargo and sensitive facilities

shelves. Tyco working with our customers be it a manufacturer, shipper, wholesaler, retailer or medical professional, helps identify weak points and put measures to help prevent hazards against the latest Which technologies/ services do you offer to the pharma sector and how effective are they?

Tyco brings more than a century of expertise helping to protect access to buildings, cargo and sensitive facilities.

Latest developments have seen these defensive caxpertise helping to protect access to buildings, cargo and sensitive facilities. Latest developments have seen these defensive capabilities combine with the latest video and radio frequency identification (RFID) technologies to monitor pharma in an unbroken chain from plant to patient. Not only do these methods help protect against outside threats, they also monitor pharma activities within facilities to help protect against internal misappropriation.

In order to provide the most comprehensive, fail-safe solutions, at Tyco, we carefully evaluate each client’s specific needs, and then integrate a seamless fire and security system that can utilise many

tactical elements, including state-of-the-art access control solutions which have been successfully deployed at thousands of plants, shipping hubs, airports, retail locations and other sensitive places where access must be tightly controlled. Video surveillance and recording, often featuring live monitoring by skilled professionals and backed up by easily searchable digital media, help prevent loss before it happens and provide valuable evidence should a crime occur.

RFID for real-time location tracking which can be discrete and deployed with any level of granularity that you require — from trucks to crates to individual pharma packages.

By knowing exactly where each shipment or package is located in real-time, it can provide not only tighter security, but a number of other inventorycontrol efficiencies. RFID also offers several advantages over other location information systems because it requires no action from personnel which can be overlooked or easily compromised. These are just a few of the technologies we use that have specialised pharma applications. We can also integrate the wide array of Tyco’s other fire detection, suppression and integrated

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PHARMA ALLY security offerings used by all types of businesses. These may include: intrusion detection, monitoring, asset management, energy management, perimeter protection etc.

How big is the global fire safety and security solutions market and what is its percentage of growth in India?

The global fire and security market is around $100 billion and is highly fragmented. In India, with increasing awareness on fire safety and security issues dominating headlines, the fire and security market has seen a growth of around 16 per cent. This is expected to grow robustly in the coming years with stricter implementation of codes and standards in the fire side and enhanced security measures being put in place by governments and private institutions to prevent untoward incidents.

Which norms need to be adhered to in order to comply with the regulatory requirements? Till now how many approvals have been obtained by your company?

National Fire Protection Association, US (NFPA) guidelines are most commonly followed to design fire protection facilities, however, many Indian states require that the fire protection facilities need to comply with the National Building Code of India (NBC) which in turn refers to

38 EXPRESS PHARMA July 1-15, 2015

Tyco is a global organisation which provides fire, security and life safety solutions across industries, verticals and countries. It is committed to help protect people, property and businesses.

The company is dedicated to advancing fire safety and security by finding innovative ways to save lives, improve businesses and protect people where they live and work several Indian product standards or codes of practices.

Some installations are also designed to European requirements. All of Tyco’s products and installations comply to international and/or national standards as required.

Every product of ours is designed to comply to well-accepted norms.

What major challenges did your company face with regards to fire safety and security?

The key challenges are having enforceable norms, lack of research facilities and general public awareness. The journey of fire safety and security in India has been a long one where some historic fire accidents have led to regulatory changes.

Fire safety and security in India has changed leaps and bounds in the last decade, now the question is not whether a fire and security system is required or not but whether the

installations work as intended.

There is now an increasing awareness on fire safety and security measures and Tyco with its two decades of presence in India has contributed significantly by bringing in a century of global experience and working very closely with influencers, regulators and end-users in India on formulation and enforcement of norms.

What other services do you offer?

We offer a complete suite of intelligent electronic fire and security offers to our customers in India, including advanced life safety gears.

From fire detection to suppression, access control to advanced video solutions, we offer the full spectrum of commercial fire and security products and solutions, along with the expertise to create integrated, security information management

systems based on our customers’ unique requirements. We also offer specialised services in intrusion detection and 24/7 monitoring with video survillance of any premises, providing additional security.

Who are your pharma clients and who are you competitors?

Globally, we serve many leading pharma companies. In India, many leading manufacturing facilities and back-end operation centres, including corporate offices of pharma majors are our customers.

Any new technologies you want to offer to the pharma sector?

We have a range of offerings across sectors. Some of the new technologies that would be of specific interest to pharma segment is water mist suppression systems used to suppress fire without causing much collateral damage to the

equipment in the room.

Middleware that can monitor and control various types of sensors/controllers can also be offered to the industry apart from leading in class technology on fire detection, suppression, access, video and energy management solutions.

What are your company's corporate plans?

Tyco is a global organisation which provides fire, security and life safety solutions across industries, verticals and countries. It is committed to help protect people, property and businesses. The company is dedicated to advancing fire safety and security by finding innovative ways to save lives, improve businesses and protect people where they live and work.

Tyco is present in India for more than two decades now.

We have a strong presence in aviation, industrial and manufacturing, commercial offices, IT & ITes, retail, networking and technology spaces, pharma and healthcare segments among others. We have been associated with many countries’ prestigious projects across segments. We will continue to bring in latest technology to India and help enhance safety and security of our Indian customers with our leading products and solutions sets. u.sharma@expressindia.com

PHARMA ALLY I N T E R V I E W

‘India is the market of the future’ Sector-specific packing and process technology provider, Optima Group, inaugurated a new India office at Bengaluru. M Neelam Kachhap met Dr Jürgen Kuske, Global CFO and MD, Optima and Akshay Chikodi, Country Head India, Optima to know more about Optima’s plans for India Tell us about the company.

Dr Jürgen Kuske: Optima Pharma is a Schwaebisch Hall-based German company with over 25 years of experience in sterile filling and capping systems as well as in the challenging field of lyophilization, isolation and containment technology. The company was founded in 1922 and is now in the third generation as a family-run business. It employs more than 1,980 people across the globe. We have 13 subsidiaries worldwide and about an export of over 80 per cent. We make tailor-made machines for customers. Technological advancement allows for the development of special single solutions as well as novel industry modules.

What is the turnover of the company?

Kuske: At Optima, the four corporate sectors i.e. pharma, consumer, non-wovens and life sciences, develop and implement sector-specific packing and packaging lines, and process technology. In the last year, our turnover was around 350 million euros half of which came from the pharma and life science division. More than 85 per cent of the sales were achieved through exports. It is very difficult to talk about market share as we serve a very niche customers and there are not similar things to compare with.

Akshay Chikodi (AC): The German packing machine industry continues to be an exception in the machinery construction sector, and we are the market leaders in some of our business. In pharma filling systems, we

40 EXPRESS PHARMA July 1-15, 2015

command 20-25 per cent market share.

Are all your machines customised?

Kuske: Our machines are tailor-made to customers’ specifications. Different customers may ask for different specifications, but all of them want safety and automation where we are highly specialised. The classical packing functions of filling and closing are combined with robotics, assembly, hygiene and sterile technologies, freeze-drying, converting and numerous other processes.

AC: All our machines are custom-made, keeping in mind all international standards. The machines are all CE certified. In fact, 80-90 per cent of our machines are specialised machines.

What are your views on India as a market?

Kuske: India is the market of the future. It is the right time to come and do business in India. When our customers

want high quality with high safety and want to invest in good machines it is the right time for us.

AC: We are not targeting all pharma companies in India.

Our target is to be able to provide specific solutions for 10-15 per cent of the pharma industry here.

Indian is a price sensitive market, so would you be making India-specific products?

AC: We are the only company that provides turn-key solutions for filling, freeze drying and isolation. Our machines are high priced.

However, our customers make products for global market mostly the US and the EU. So, they have to have very high safety standards and quality.

India is price sensitive but our technology is unmatched and we provide excellent services to our customers.

What is your plan for the India office?

Kuske: We have shifted to a new office and hope to get

Technological advancement allows for the development of special single solutions as well as novel industry modules

The German packing machine industry continues to be an exception in the machinery construction sector

DR JÜRGEN KUSKE

AKSHAY CHIKODI

more sales from the country.

In India we function under OPTIMA India Packaging Machines. We are also looking at enhancing our after sales service here.

AC: The India office achieved about five million euros last financial and we hope to double our revenue in the next year. Our sales cycle is very long from about six months to

an year because it is a huge capex investment. Our strategy is to grow slow and steady.

Any last words.

Kuske: We take care of our people both internal and external. mneelam.kachhap@ expressindia.com

PHARMA ALLY VENDOR NEWS

SCHOTTachieves GMP certification for all pharma tubing sites Production unit in India successfully audited by TÜV Rheinland SCHOTT’S FIOLAX glass tubing plant in Gujarat has achieved official Good Manufacturing Practice (GMP) compliance. The certificate, presented to SCHOTT by TÜV Rheinland, underlines the company’s global commitment to those standards. In fact, SCHOTT is now the only supplier of pharmaceutical tubing worldwide to be GMP certified at all its manufacturing sites.

The GMP guidelines comprise a series of general principles that must be observed during the manufacturing process. More and more coun-

tries are specifying GMP as a statutory requirement that pharma companies and suppliers of quality related components to the industry must meet.

“SCHOTT considers quality assurance central to the production of pharma glass,” explained Dr-Ing. Karsten Hennig, Director of Quality Management at SCHOTT Tubing. Hennig continued, “It is therefore established practice for SCHOTT to work as per GMP standards at all our facilities.”

SCHOTT manufactures glass tubing in Europe, South

SCHOTT manufacture s glass tubing in Europe, South America and Asia

America and Asia, with a total production capacity of more than 140,000 tonne. Tubes made of FIOLAX speciality glass are the basis of many pharma packaging solutions, being converted into syringes, vials, ampoules, and cartridges. These containers need to safely store medication, sometimes for years, without compromising the efficacy of the drug, implying that the quality of glass is the key.

“In order to provide patients with safe pharma products of the highest standard, quality is top priority throughout the production value

chain,” said Georg Sparschuh– President SCHOTT Pharmaceutical Tubing, India. He further stated, “GMP certificate is yet another proof that our production site ensures best quality and utmost safety measures to manufacture pharma glass. By earning GMP certification at our production site in India, we are helping our customers eliminate all potential risks from the very beginning. This helps establish confidence amongst our pharma manufacturing partners,” Sparschuh added.

EP News Bureau-Mumbai

Exostar partners with SIGNiX To deliver secure, compliant digital signature solution to life science and healthcare EXOSTAR, AN innovative information technology company offering cloud-based solutions that enable secure, cost-effective business-to-business collaboration, and SIGNiX, provider of Independent E-Signatures, announced a partnership that brings SIGNiX’s digital signature solution to Exostar’s life science and healthcare communities. With SIGNiX becoming Exostar’s latest Application Partner, organisations and individuals connected to Exostar’s Life Sciences Identity Hub can leverage secure, single sign-on access to SIGNiX to quickly and easily sign business-critical and sensitive documents and forms online.

SIGNiX’s Independent ESignatures comply with global

life sciences and healthcare industry standards and regulations, including the FDA’s 21 CFR Part 11, HIPAA, and the ESIGN Act. They have also been approved by the SAFEBioPharma Association, the non-profit organisation that manages digital identity and signature standards for the pharma, biotech, and healthcare industries.

Researchers, investigators, patients, providers, and clinical trial participants benefit from signature process enforcement, faster document turnaround, reduced operating costs, and the flexibility to sign, send, and track documents from any device with an internet connection.

Users determine where documents reside, including on their

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Exostar’s cloud-based Life Sciences Identity Hub supports a community of nearly 1,000 organisations and 20,000 individuals worldwide own servers, rather than the vendor’s external server. Legal evidence is permanently embedded into the signed document so that signatures can be verified offline, anytime. Since the legal evidence behind each signature is permanently embedded into the signed document and signatures adhere to international, published standards, they are valid virtually forever, as long as

a digital copy of the signed document exists. Users get immediate and complete access to the evidence of the signature’s validity through a comprehensive audit trail.

Exostar’s cloud-based Life Sciences Identity Hub supports a community of nearly 1,000 organisations and 20,000 individuals worldwide in their life science and healthcare endeavours.

It serves not only as a platform that enables secure, internal and external collaboration, but also as a single sign-on entry point to a wealth of connected applications and solution provider portals that advance business objectives. Owners of connected assets define permission and user authentication strategies and rules, which are enforced by Exostar’s Secure Access Manager. Coupled with extensive platform security and audit capabilities, application providers receive a secure connection experience, while sponsor organisations are assured their sensitive information and intellectual property are protected from compromise.

EP News Bureau-Mumbai

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PHARMA ALLY

Lonza to expand viral gene therapy biz Plans to construct a new state-of-the-art 100,000 square foot facility (9,300 square metres) in the Houston, TX LONZA ANNOUNCED the planned expansion of its industry-leading viral gene therapy business. Lonza plans to construct a new 100,000 square foot facility for viral and immunotherapy development and manufacturing in the Houston, TX (US) area, complete with a fully segregated fill/finish suite. This new facility will more than double Lonza’s capacity for the production of viral gene and virally modified therapeutics.

The state-of-the-art multipurpose facility is expected to come on-line in the first half of 2017 and will include eight independent cGMP modular cleanrooms for 2,000 L-scale production in single-use bioreactors. Grade-B cleanrooms will also be constructed to continue the manufacture of EMA-regulated cell therapy products. The site master

The state-ofthe-art multipurpose facility is expected to come on-line in the first half of 2017 and will include eight independent cGMP modular cleanrooms plan includes expanded process development and quality-control areas, shell space for future additional

cleanrooms, and land for further potential expansions.

“The clinical landscape for targeted gene therapies continues to grow at a steady rate with new advancements in cancer immunotherapies and cardiovascular disease,” said Andreas Weiler, Head of Emerging Technologies, Lonza’s Pharma and Biotech segment. “This investment will allow Lonza to be well positioned to meet the demands of this growing market and to remain at the forefront of the viral gene therapy industry.

Our viral team has more than 20 years of experience in viral vector gene therapy that, when combined with our newly constructed leading edge facility, will provide a key advantage to our customers and ultimately to their patients.”

EP News Bureau-Mumbai

Quintiles introduces Infosario One Mobile App Key stakeholders in the drug development process can conveniently access site start-up, recruitment and compliance information QUINTILES IS extending its award-winning Quintiles Infosario technology platform with mobile access to critical clinical trial information. Using the mobile app, key stakeholders in the drug development process can conveniently access site startup, recruitment and compliance information as well as status updates on data queries and project milestones.

“With so much at stake in the successful delivery of development programs, faster decision making is fundamental,” said Margaret Keegan, Senior Vice President of Data Sciences and Strategy, Quintiles. “Infosario One provides instant and intuitive access to

insights at your fingertips, wherever and whenever you need them.

The Infosario One mobile app can be personalised with different filters so users can quickly see precisely what’s most important to them.

These customised views are then served up in mobilefriendly charts that automatically reflect the latest information. Increasing complexity in the delivery of clinical trials — and the related information overload — can slow down progress or obscure valuable information,” said Alejandro Martinez, Chief Information Officer, Quintiles.

EP News Bureau-Mumbai

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42 EXPRESS PHARMA July 1-15, 2015

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021.

Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 editorial.ep@expressindia.com

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Call for the best quote Exclusive Package : Ex- Delhi/Mumbai

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CPhI worldwide

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For more details call @

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Exhibitor Packages also available!

Date

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Depart India, Arrive Madrid

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CORPORATE OFFICE:

REGIONAL OFFICE:

23/1, First Floor, East Patel Nagar, New Delhi - 110008, Tel: 011 - 46 275 275, Email: redcarpettours@redcarpettours.net

G 29, Fantasia Business Park, Nano Wing, Sec - 30/A, Vashi, Navi Mumbai - 400705, Tel: 022 - 66 737 435/36/37/38

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The one stop solution

Wow!!

To your packaging problem!!! Wow!!

Anti-staticjumbo bags are also available !!!

Small or large, printed, laminated, food grade Metallized / Aluminum foil, Stand up, gusseted sachets or bags for sending valuable samples to domestic and foreign customers or export of bulk drugs in most attractive and appealing manner D&B D-U-N-6 No. 86-334-9695

Mr. Ashesh Ghose C.E.O

TER ck a POR : EX . Roll P N T o T !!! A !! File N W E !

N NG F Type AKI M BRE allats D A USD

Now we are on facebook & also Our Italian Solvent Recovery machine re-affirms our Commitment to Clean Green sustainable Economy

We are the leading Indian manufacturers of large or small laminated, food grade, metallized or aluminium foil, aroma relentive, oxygen-resistant, moisture-resistant, moisture-resistant, light resistant / opaque double laminated or triple laminated bags or quad laminated sachets!!! at (022) 25646033, 25612887 Mobile : 9322248050 Email: rollspac@vsnl.com, rollspac@mtnl.net.in Website: www.rollspack.com

Rolls Pack Pvt. Ltd / Unipack Pvt.Ltd

Unit No. 11, Bishan Udyog Industrial Estate, Mulund West, Mumbai - 400 080.Maharashtra

ISO9001 : 2008 CERTIFIED

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Two great brands come together under Charles River to provide an even stronger testing solution for our customers.

Microbial Detection & Identification

Charles River Laboratories India Private Limited Bangalore (Regd. Office): Phone: 080 25588175 / 76 / 77. Email: blroffice@crl.com Ahmedabad: Phone: 079 40194730. Email: ahdoffice@crl.com Hyderabad: Phone: 040 27179998. Email: hydoffice@crl.com Mumbai: Phone: 022 27810061. Email: bbyoffice@crl.com Mumbai - Accugenix Facility: Phone: 022 41270504 / 05 / 08. Email: CRLIaccugenix@crl.com

www.criverindia.com

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Innovation is our culture…

Preclinical Toxicology Services: Single dose (Acute ) toxicity studies Repeated dose (14, 28, 90 & 180 Days) toxicity studies • Skin, Eye Irritation / corrosion • Skin Sensitization • Pharmacokinetic studies on Beagle dogs • LD50 and maximum tolerated dose • Immunotoxicity • Genotoxicity Studies • •

Test Systems: • Mouse (Balb-C, Swiss-Albino, C57, Diabetic) • Rat (Sprague Dawley, Wistar) • Rabbit (New Zealand White, Non albino) • Guinea Pig (Hartley) • Canine (Beagle Dogs)

SERVICES Formulation Development.

Microbiological Studies.

Biological Studies.

Pre Clinical Studies.

Analytical Research.

Bio-equivalence Studies.

Clinical Trials.

Dossier Preparation.

Preclinical Pharmacopoeial Services.

Quality in our genes…

Pharmacopoeial Services: (Accredited by NABL for ISO/IEC 17025:2005)

• • • • • • • •

Pyrogen Testing Abnormal Toxicity Undue Toxicity Bioassays Systemic Injection Test Intracutaneous Test Implantation Test Eye Irritation Test

Facility Infrastructure: Individually Ventilated Cages Designed as per GLP/ AAALAC Independent facility for Rats, Mice Rabbits and Beagle Dogs • Ultra modern Histopathology lab • Safety alarms/call to scientists • Online Recording of Observations • • •

ACCREDITATIONS USFDA registered cGMP control testing laboratory.

DSIR approved R & D Centre.

Drugs Controller General of India (DCGI).

NABL accreditation for Chemical, Biological Medical Testing, Bioanalytical & Mechanical.

Recognized by Bureau of Indian Standards.

Drugs Control Administration (A.P).

Department of Biotechnology approved Institutional Bio-Safety Committee (IBSC).

NABL for ISO/IEC 17025:2005.

!"! $!%!&'('%" )*!+",+'- ,% ./012 324. !*' 5'-,&%'5 "6 '%-7*' "6"!8 ,%"'&*,"9: -'+7*,"9 !%5 ;!-"'-" *'"*,'<!8=

ONE STOP SOLUTION FOR PHARMACEUTICAL RESEARCH

SIPRA LABS LIMITED Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Industrial Estate, Sanathnagar, Hyderabad – 500 018.

Tel: 040-23802000, Fax: 040-23802005 Email:sipra@sipralabs.com web: www.sipralabs.com EXPRESS PHARMA

July 1-15, 2015 49

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XRD-Mill McCrone

The new XRD-Mill McCrone was specially developed for the preparation of samples for subsequent X-ray diffraction (XRD) n Crystal lattice preserved during grinding operation n Very narrow and reproducible particle size distribution n Minimal cross contamination n Compact, bench-top sized model n Adjustable grinding power (4 steps) n Suitable for dry and wet grinding

MACHINERY FOR SALE STABILITY CHAMBERS

1 CONDITION

CHAMBER SIZE (H x W x D in cm)

125 x 60 x 60 125 x 60 x 60 70 x 50 x 50

40°C/75%RH 30°C/75%RH 25°C/60%RH

2

CLASS 100 TYPE DHS Heater:

39 KW

Working Temp.:

275°c

Motor:

7.5 HP

Electric supply :

415V-3PH-50HZ AC

Make:

Triton Engg. P. Ltd.

Make

Capacity/Technical Specification

Capacity - 150 Ltr/ Hrs.

Machine Febric

1

4 Ampoule Inspection 5 DHS

Envee Pharma

1

6 Head

Machine Fabrics

1

Capacity - 1250 Ltrs.

6 Auto cleave

Machine Fabrics

1

Gopinath

1

Techno

1

York Scientic Industries

1

Not available

1

Steam Ketal Half Lift Incubator Small Blower

inspection m/c

July 1-15, 2015

Nos.

3 Multicolumn with part

11 Automatic visual

50

EIE INSTUMENTS PVT.LTD

1120 (W) x 1400 (D) x 1280 (H)

7 8 9 10

VERDER SCIENTIFIC PRIVATE LIMITED Plot No – 5A/10-11, ID Nacharam, Uppal Mandal, 500076, Hyderabad, India Phone: +91 40 2717 2431 | Fax: +91 40 2715 4686 E-mail: info@verder-scientific.co.in | www.verder-scientific.co.in

450 liters 450 liters 175 liters

COMPANY NAME

Chamber size:

Name of Machine

www.retsch.com

VOLUME OF THE CHAMBER

Envee Pharma

2

Connected load – 1.5HP , 415V

Size - 450(W) x 450(H) x 600(D) connected load – 3 HP, 415 volt Working Pressure – 2.2Kg/cm2 50 Ltr. Kg 1500 Kg (Aprox) 90 Ltr. (Aprox) 300 CFM (Aprox) 1) No. of head: 6 head with loading & unloading hopper facility.

2) Capacity: 2600 Amps./hr 3) Magnifying glass for better viewing of rejection.

4) Six nos. of rejection switch for the auto removal of individual rejection.

5) Suitable for 1 to 5 ml Amps. with different change part for each size of amps.

6) Three phase supply

Troikaa Pharmaceuticals Ltd. Please contact: Mr. Bhavin Upadhyay-09879615621, 079-26856242-45. Email.: bhavin@troikaapharma.com

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Associates

Rotary & Fixed Spray Balls

Diaphragm Valves

Aseptic Sampling Valves

Drain Trap

Product Range : Associates

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July 1-15, 2015

Lobe Pump

Centrifugal Pump

Sight Glass :

Powder Ventury Sanitary Manually & Triblender Pneumatically Butterfly Valve

Sanitary Fittings

Elliptical Manhole

Sanitary Pumps Sanitary Auto / Manual Valves

Steam Water Sanitary Mixing Battery Pneumatic Valve Manually Controlled

Sanitary Fittings Stainers

Safety Valve

Manholes Sight Glass

S. No. 28/27, Near Pari Company, Dhayari - Narhe Road, Pune - 411 041. Ph. : + 91 - 020 - 6500 1482 / 2469 0268 Fax : + 91 - 020 - 2469 0268 Mob. : + 91 90287 16622, + 91 99231 24949 Email : swastikpune@gmail.com / sales1swastik@gmail.com

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OSMOMETER 3250

Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

Advertise in

Business Avenues Please Contact: ■ Mumbai, Ahmedabad: Rajesh Bhatkal 09821313017 ■ Delhi: Ambuj Kumar 09999070900 ■ Chennai: Arun J 91-9940058412 ■ Bangalore: Khaja Ali 09741100008 ■ Hyderabad: Mujahid 09849039936 ■ Kolkata: Ajanta 09831182580 58

July 1-15, 2015

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PharmaTainersTM-Clean containers

Single-Use Containers for Storage & Transportation of Vaccines, Biopharmaceuticals, Culture Media and other Biotech Materials (Polyethylene terephthalate (PET) & Polycarbonate (PC), with High Density Polyethylene (HDPE) closures) Details • • • • • • •

Clean, sterile & ready-to-use Medically approved resins Molded and capped in an ISO Class 5 (class 100) environment, Precision, injection molded, flash and burr-free neck finish eliminate the primary cause of seal failure Unlined, double seal closure system PET PharmaTainersTM have excellent gas barrier properties; PC Pharmatainers are ideal for freezing applications Each container is printed with a unique serial number, batch number, expiration date and machine readable data matrix for unrivalled traceability troughout production and during use

Compliance 3

Certified to meet USP788, EP, JP compendia standards

3

Endotoxins tested

3

Packed in an ISO Class 7 (Class 10,000) cleanroom

Traceability

Double Seal Closure System

ULTRA LOW PARTICULATES USP788 EP2.9.19 JP 14 ed. part 1 sect 24. th

Raw Material

Sterility

Manufactured from 100% virgin ADCF resins that are approved for medical applications

Precision molded closures and necks have robust threads that provide secure engagement between cap and bottle. Closures seal at two points - inside the neck and on the rim of the neck to provide a leak proof seal.

Each container is printed with a unique serial number, lot number, expiration date and machine readable data matrix to provide unrivalled traceability through the production process.

PET

PC

HDPE

medical use

Yes

Yes

Yes

USP Class VI

Yes

Yes

Yes

In-vitro cytotoxicity Test

Yes

Yes

Yes

DMF15205

DMF1562

DMF1646

Approved for

Drug master file ADCF*

Yes Yes Yes *Animal derived component-free

PharmaTainerTM Polycarbonate Bottles & Carboys

PharmaTainerTM PET Bottles & Carboys

Polycarbonate has a wide

PET provides excellent gas

temperature range of use.

barrier properties. Phar-

PharmaTainersTM PC bottles

maTainerTM PET bottles and

& carboys are ideal for frozen

carboys are ideal for long

storage.

storage of materials like

Pharma TainerTM product families sterility certification is based on a VDmax 25 sterilisation study performed according to “ISO11137-2:2007, VDmax 25 sterilisation of healthcare products radiation-part 2”, which demonstrates that a 25kGy irradiation dose achieves a sterility assurance level (SAL) of 10-6. Ongoing sterility assurance is maintained by bioburden assessments on every product batch and quarterly VDmax 25 dose audit studies.

culture media.

Volume : 125 ml, 500 ml, 1, 2, 5, 10 & 20 liters

Volume : 125 ml, 500 ml, 1, 2, 5, 10 & 20 liters

Temperature range of use : -130°C to +120°C

Temperature range of use : -40°C to +60°C

Clear and easy-to-read graduations with an accurancy of +/- 2 %

Clear and easy-to-read graduations with an accurancy of +/- 2 %

Certified sterile and endotoxins tested

Certified sterile and endotoxins tested

Genetix Biotech Asia Pvt. Ltd. 71/1, First Floor, Shivaji Marg, Najafgarh Road, New Delhi-110015 E-mail : info@genetixbiotech.com, Web : www.genetixbiotech.com

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PHARMA LIFE INSIGHT

Comply or face hefty penalties and jail Vishal Kedia, Founder & Director, Complykaro informs that organisations need to take The Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013 very seriously and non-compliance with it can invite trouble for the management, including criminal prosecution SEXUAL HARASSMENT at workplace can blow into a major HR issue. Many women face sexual harassment at workplace. It could come in any form from indecent proposals, jokes, innuendos, ogling, inappropriate remarks, pictures, text messages and MMS. Women do not complain fearing job loss and the stigma of being a ‘nasty cribber.’

Some organisations consider this harmless and refuse to recognise the difference between a compliment and harassment.

These incidents may lead to a cycle of depression, loss of morale and motivation. It can cause under-performance and absenteeism; all of which contributes to a hostile work environment. Aggrieved women feel insecure and quit jobs and organisations lose trained employees while the time and resources spent on training simply go waste.

To tackle this menace, the Government enacted The Sexual Harassment of Women at Workplace (Prevention, Prohibition and Redressal) Act, 2013 on December 9, 2013, but unfortunately most organisations do not seem to be aware of this law.

Organisations, however, can no longer dismiss workplace sexual harassment with a ‘Chalta Hai’ attitude. This law is mandatory for every organisation whether they have women employees or not. In fact, the Maharashtra government has already amended their Shop & Establishment and Factory Rules mandating disclosures regarding compliance and incidences of sexual harassment in their annual submissions.

The Indian pharma market is third largest in terms of volume and thirteen largest in terms of

64 EXPRESS PHARMA July 1-15, 2015

Women do not complain fearing job loss and the stigma of being a ‘nasty cribber.’

Some organisations consider this harmless and refuse to recognise the difference between a compliment and harassment value, as per a pharmaceuticals sector analysis report by Equity Master. As per Kiran Mazumdar Shaw of Biocon, the doyenne of the Indian pharma sector, over 20-30 per cent of the total workforce now is female but the manufacturing and marketing functions continue to be maledominated. Medical Sales Representatives (also known as MR, ABM, and PSR) are responsible for the promotion of products among physicians, hospitals and pharmacies and they are mostly males.

Medical Sales Representatives whether on payroll or otherwise are considered employees of the organization for the purpose of this Act. The aggrieved women can be a doctor, a female patient waiting for her turn in a dispensary or hospital, customer or vendor and as long as she alleges that an employee, Medical Sales Representative, etc. whilst performing their duty sexually harassed her whether within office premises or outside, you (as the employer) are responsible for providing assistance and redressal of such complaints.

Every organisation i.e. public limited company, private limited company, limited liability partnership, partnership firms, association, society, trust, proprietorship, NGO, etc. irrespective of

size and number of employees has to comply with the said Act. Failure to comply with the law could lead to hefty penalties, imprisonment and even closure of business. In fact a company in Chennai, where a woman complained of sexual harassment, was fined ` 1.68 crores for its failure to comply with the law.

The law is clear. Non-compliance with the law can invite trouble for the management, from fines to shutting down of businesses. They even face charges of abettment of the crime and criminal prosecution, as well.

Further compliance with the said Act needs to be reported in the Annual Report to be filed by the organisations and where no such annual report needs to be prepared; the organisation has to file a report with the district officer each year. The law provides for penalty up to ` 50,000 for such non-disclosure and double the penalty and closure of business on successive defaults.

In fact, a few listed companies like Cipla had complied with such disclosure requirements in their Annual Report for year ending March 31, 2014.

Law mandates that each organisation has to formulate an Anti-Sexual Harassment Policy and put up posters within their premises highlighting penal con-

sequences of sexual harassment.

Where the organisations employ 10 or more workers as a whole, the organisation has to mandatorily constitute an Internal Complaints Committee (ICC) at each location to redress complaints. The Committee is headed by a senior women employee apart from minimum two other employee members and one external representative who may be an NGO member or an Advocate. Minimum 50 per cent of the said members must necessarily be women.

In case of organisations which employ up to nine workers or where the complaint is against the senior management / business owners, such complaints are heard and decided by the Local Complaints Committee (LCC) constituted in each district. Hence, a redressal forum has been provided with respect to every organisation, big or small.

All employees including medical sales representatives of the organisation must necessarily undergo sensitisation training each year as the emphasis of the law is prevention of instances of sexual harassment.

It is pertinent to note that it is not the intention of the harasser which matters but the impact of such incidents on the aggrieved woman. Hence even a

VISHAL KEDIA, Founder & Director, Complykaro

single instance of a WhatsApp forward of an indecent joke or picture can trigger a complaint.

The incident must be perceived as unwelcome by the aggrieved woman, irrespective of its intent. Hence, what may be sexual harassment in a normal situation may not be construed as sexual harassment in a consensual and romantic relationship. The simple mantra is that in case of doubt err on the side of caution and avoid any behaviour which can be construed otherwise.

Even the ICC members need to undergo skill building training as they are a fact finding body which needs to adhere to principles of natural justice with powers of the civil court whilst hearing and deciding the complaint.

Further recommendations of the ICC are challengeable before the Industrial Tribunal.

In their annual report to be submitted to the organisation and district officer, the ICC has to disclose the training and sensitisation programmes organised by the organisation during the year amongst other facts.

By complying with the said law, management of organisations can shield themselves from any legal consequences and ensure that prompt remedial action is taken against the perpetrator i.e. accused in case of genuine complaints and the complainant in case of false and malicious complaints.

Even the Union Minister for Women, Maneka Gandhi admitted in Rajya Sabha recently that most government offices and 90 per cent of private firms have not complied with the law. She has issued a stern warning to India Inc to comply with the said law or face severe consequences.

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.

IDEAL CURES

BECOMES FIRST INDIAN COMPANY TO RECEIVE EXCIPACT

CERTIFICATE

Ideal Cures has received Excipact certification for two of its manufacturing plants.

CORPORATE OFFICE & R & D CENTRE - II Ideal Cures Pvt. Ltd. Unit No. A/223 to A/229, 2nd Floor, Virwani Industrial Estate, Western Express Highway, Goregaon (E), Mumbai - 400 063. Tel.: +91-22-42688741 Fax : +91-22-42688713 Visit us at : www.idealcures.com / www.idealcures.co.in